{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "209889", "product_res_number": "Z-0044-2025", "event_date_initiated": "2024-08-07", "event_date_posted": "2024-10-09", "recall_status": "Open, Classified", "res_event_number": "95277", "product_code": "OLO", "k_numbers": [ "K093425" ], "product_description": "MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063", "code_info": "GTIN: 00848486030193;\nSerial Numbers:\n4200075\n4200134\n4200177\n4200179\n4200191\n4200234\n4200235\n4200251\n4200339\n4200351\n4200359\n4200387\n4200427\n4200461\n4200510\n4200515\n4200531\n4200602\n4200608\n4200611\n4200639\n4200641\n4200648\n4200650\n4200653\n4200671\n4200697\n4200709\n4200712\n4200729\n4200734\n4200757\n4200850\n4200856\n4200868\n4200873\n4200898\n4200902\n4200966\n4201034\n4209747\n4209750\n4209781\n4209789\n4209803\n4209821\n4209864\n4209866\n4209878\n4209882\n4209899\n4209900\n4209950\n4209955\n4209967\n4210004\n4210033\n4210039\n4210051\n4210086\n4210092\n4210098\n4210167\n4210211\n4210213\n4210220\n4210265\n4210267\n4210325\n4210329\n4210359\n4210408\n4210418\n4210439\n4210445\n4210455\n4210503\n4210505\n4210509\n4210522\n4219193\n4219267\n4219400\n4219446\n4219535\n4219682\n4219702\n4219881\n4220005\n4220154\n4220230\n4220237\n4220263\n4220451\n4220452\n4220810\n4220836\n4221090\n4221102\n4221103\n4221106\n4221243\n4221268\n4221335\n4221462\n4221471\n4221563\n4221685\n4221808\n4222927\n4222994\n4222995\n4222996\n4222997\n4222998\n4222999\n4223000\n4223001\n4223003\n4223004\n4201045\n4201114\n4201124\n4201157\n4201200\n4201235\n4201242\n4201254\n4201270\n4201272\n4201303\n4201332\n4201363\n4201371\n4201400\n4201403\n4201410\n4201415\n4201417\n4201469\n4201520\n4201527\n4201551\n4201555\n4201556\n4201557\n4201562\n4201604\n4201620\n4201640\n4201673\n4201678\n4201692\n4201762\n4201771\n4201822\n4201824\n4201830\n4201858\n4201919\n4201933\n4210539\n4210543\n4210558\n4210575\n4210583\n4210587\n4210590\n4210599\n4210603\n4210604\n4210610\n4210620\n4210626\n4210721\n4210746\n4210831\n4210846\n4210850\n4210924\n4210946\n4211026\n4211033\n4211087\n4211102\n4211103\n4211201\n4211205\n4211217\n4211232\n4211233\n4211243\n4211261\n4211268\n4211273\n4211291\n4211315\n4211320\n4211321\n4211391\n4211413\n4211434\n4223005\n4223006\n4223007\n4223008\n4223009\n4223010\n4223011\n4223012\n4223014\n4223015\n4223016\n4223017\n4223018\n4223019\n4223020\n4223021\n4223022\n4223023\n4223024\n4223025\n4223026\n4223027\n4223028\n4223029\n4223030\n4223031\n4223032\n4223033\n4223034\n4223035\n4223036\n4223037\n4223038\n4223039\n4223040\n4223053\n4223054\n4223055\n4223056\n4223057\n4223058\n4201935\n4201941\n4201942\n4202012\n4202025\n4202029\n4202030\n4202036\n4202070\n4202093\n4202126\n4202127\n4202128\n4202136\n4202175\n4202188\n4202253\n4202258\n4202262\n4202272\n4202286\n4202307\n4202328\n4202330\n4202348\n4202349\n4202382\n4202396\n4202411\n4202421\n4202429\n4202500\n4202511\n4202560\n4202596\n4202619\n4202652\n4202694\n4202732\n4202807\n4202856\n4211459\n4211466\n4211540\n4211557\n4211569\n4211658\n4211660\n4211669\n4211688\n4211700\n4211711\n4211734\n4211736\n4211773\n4211777\n4211781\n4211793\n4211794\n4211798\n4211803\n4211821\n4211830\n4211865\n4211874\n4211883\n4211893\n4211900\n4211936\n4211940\n4211947\n4211956\n4211961\n4211971\n4211978\n4211996\n4212022\n4212029\n4212136\n4212207\n4212226\n4212231\n4223059\n4223060\n4223061\n4223062\n4223063\n4223064\n4223065\n4223066\n4223067\n4223068\n4223069\n4223070\n4223071\n4223072\n4223073\n4223074\n4223075\n4223076\n4223077\n4223078\n4223079\n4223080\n4223081\n4223082\n4223083\n4223084\n4223085\n4223086\n4223087\n4223088\n4223089\n4223090\n4223091\n4223096\n4223103\n4223104\n4223105\n4223106\n4223107\n4223108\n4223109\n4202896\n4202901\n4202910\n4202922\n4202941\n4202971\n4203002\n4203019\n4203020\n4203088\n4203093\n4203104\n4203118\n4203150\n4203163\n4203167\n4203174\n4203178\n4203183\n4203202\n4203224\n4203226\n4203236\n4203270\n4203281\n4203285\n4203313\n4203348\n4203369\n4203373\n4203389\n4203391\n4203393\n4203397\n4203401\n4203451\n4203503\n4203520\n4203521\n4203545\n4203556\n4212275\n4212290\n4212341\n4212385\n4212463\n4212491\n4212508\n4212534\n4212543\n4212563\n4212581\n4212619\n4212652\n4212678\n4212692\n4212696\n4212697\n4212700\n4212737\n4212743\n4212747\n4212779\n4212787\n4212788\n4212791\n4212799\n4212803\n4212863\n4212868\n4212917\n4212931\n4212935\n4212938\n4212951\n4212959\n4212976\n4212979\n4212981\n4213029\n4213033\n4213034\n4223110\n4223111\n4223112\n4223113\n4223114\n4223115\n4223128\n4223129\n4223130\n4223131\n4223132\n4223133\n4223134\n4223135\n4223136\n4223137\n4223138\n4223139\n4223140\n4223141\n4223142\n4223143\n4223144\n4223145\n4223146\n4223147\n4223148\n4223149\n4223150\n4223151\n4223152\n4223170\n4223176\n4223177\n4223178\n4223179\n4223180\n4223181\n4223182\n4223183\n4223184\n4203571\n4203576\n4203580\n4203614\n4203620\n4203756\n4203797\n4203804\n4203865\n4203935\n4203955\n4204008\n4204025\n4204031\n4204054\n4204078\n4204079\n4204087\n4204090\n4204149\n4204192\n4204210\n4204219\n4204250\n4204264\n4204276\n4204277\n4204280\n4204303\n4204314\n4204318\n4204319\n4204324\n4204325\n4204351\n4204377\n4204396\n4204409\n4204414\n4204419\n4204473\n4213040\n4213067\n4213075\n4213083\n4213090\n4213095\n4213103\n4213105\n4213111\n4213119\n4213129\n4213136\n4213174\n4213177\n4213192\n4213215\n4213260\n4213262\n4213277\n4213289\n4213316\n4213325\n4213353\n4213365\n4213367\n4213375\n4213395\n4213400\n4213426\n4213461\n4213462\n4213463\n4213467\n4213469\n4213474\n4213511\n4213512\n4213518\n4213535\n4213545\n4213556\n4223185\n4223186\n4223187\n4223188\n4223190\n4223191\n4223192\n4223193\n4223194\n4223195\n4223196\n4223197\n4223198\n4223199\n4223200\n4223201\n4223202\n4223203\n4223204\n4223205\n4223206\n4223207\n4223208\n4223209\n4223210\n4223211\n4223212\n4223213\n4223214\n4223215\n4223216\n4223217\n4223218\n4223228\n4223229\n4223230\n4223231\n4223232\n4223233\n4223234\n4223235\n4204476\n4204492\n4204534\n4204591\n4204598\n4204600\n4204605\n4204637\n4204663\n4204667\n4204669\n4204685\n4204690\n4204702\n4204713\n4204781\n4204803\n4204853\n4204855\n4204879\n4204907\n4204935\n4204938\n4204946\n4204947\n4204952\n4204969\n4204981\n4204995\n4205015\n4205066\n4205086\n4205110\n4205111\n4205118\n4205122\n4205125\n4205129\n4205135\n4205163\n4205186\n4204476\n4204492\n4204534\n4204591\n4204598\n4204600\n4204605\n4204637\n4204663\n4204667\n4204669\n4204685\n4204690\n4204702\n4204713\n4204781\n4204803\n4204853\n4204855\n4204879\n4204907\n4204935\n4204938\n4204946\n4204947\n4204952\n4204969\n4204981\n4204995\n4205015\n4205066\n4205086\n4205110\n4205111\n4205118\n4205122\n4205125\n4205129\n4205135\n4205163\n4205186\n4223236\n4223237\n4223238\n4223239\n4223240\n4223253\n4223254\n4223255\n4223256\n4223257\n4223258\n4223259\n4223260\n4223261\n4223262\n4223263\n4223278\n4223279\n4223280\n4223281\n4223282\n4223283\n4223284\n4223285\n4223286\n4223287\n4223288\n4223289\n4223290\n4223291\n4223303\n4223304\n4223305\n4223306\n4223307\n4223308\n4223309\n4223310\n4223311\n4223312\n4223313\n4205220\n4205222\n4205224\n4205225\n4205287\n4205299\n4205333\n4205388\n4205444\n4205471\n4205549\n4205550\n4205551\n4205588\n4205589\n4205602\n4205606\n4205644\n4205658\n4205685\n4205686\n4205714\n4205737\n4205749\n4205761\n4205795\n4205823\n4205825\n4205877\n4205907\n4205925\n4205965\n4205983\n4205993\n4206000\n4206003\n4206012\n4206034\n4206041\n4206063\n4206104\n4214459\n4214464\n4214471\n4214567\n4214571\n4214585\n4214591\n4214635\n4214644\n4214653\n4214686\n4214703\n4214724\n4214728\n4214776\n4214777\n4214781\n4214865\n4214875\n4214888\n4214913\n4214920\n4214926\n4214980\n4215036\n4215038\n4215063\n4215065\n4215067\n4215069\n4215070\n4215111\n4215122\n4215133\n4215150\n4215185\n4215187\n4215193\n4215206\n4215239\n4215284\n4223314\n4223315\n4223316\n4223328\n4223329\n4223330\n4223331\n4223332\n4223333\n4223334\n4223335\n4223336\n4223337\n4223338\n4223339\n4223340\n4223341\n4223342\n4223353\n4223354\n4223355\n4223356\n4223357\n4223358\n4223359\n4223360\n4223361\n4223362\n4223363\n4223364\n4223365\n4223366\n4223367\n4223368\n4223369\n4223370\n4223371\n4223372\n4223373\n4223374\n4223375\n4206109\n4206121\n4206135\n4206148\n4206178\n4206181\n4206252\n4206272\n4206280\n4206285\n4206315\n4206327\n4206373\n4206389\n4206401\n4206402\n4206405\n4206408\n4206413\n4206420\n4206451\n4206479\n4206533\n4206572\n4206590\n4206594\n4206599\n4206655\n4206659\n4206664\n4206687\n4206696\n4206699\n4206762\n4206772\n4206822\n4206829\n4206854\n4206903\n4206932\n4206946\n4215337\n4215338\n4215342\n4215349\n4215351\n4215352\n4215382\n4215393\n4215413\n4215418\n4215434\n4215440\n4215441\n4215449\n4215459\n4215474\n4215551\n4215585\n4215612\n4215614\n4215666\n4215683\n4215690\n4215709\n4215725\n4215737\n4215778\n4215780\n4215817\n4215831\n4215842\n4215851\n4215943\n4216021\n4216024\n4216113\n4216116\n4216163\n4216184\n4216240\n4216245\n4223376\n4223377\n4223403\n4223404\n4223405\n4223406\n4223407\n4223408\n4223409\n4223410\n4223411\n4223412\n4223413\n4223414\n4223415\n4223416\n4223417\n4223418\n4223419\n4223420\n4223421\n4223422\n4223423\n4223424\n4223425\n4223426\n4223427\n4223432\n4223451\n4223452\n4223453\n4223454\n4223455\n4223456\n4223457\n4223458\n4223459\n4223460\n4223461\n4223462\n4223463\n4206979\n4206998\n4207025\n4207026\n4207055\n4207072\n4207075\n4207118\n4207182\n4207230\n4207279\n4207322\n4207327\n4207339\n4207377\n4207394\n4207410\n4207416\n4207427\n4207434\n4207453\n4207466\n4207500\n4207511\n4207553\n4207559\n4207581\n4207594\n4207600\n4207602\n4207605\n4207615\n4207639\n4207645\n4207656\n4207665\n4207681\n4207696\n4207723\n4207767\n4207787\n4216257\n4216302\n4216331\n4216334\n4216351\n4216372\n4216373\n4216378\n4216383\n4216424\n4216451\n4216464\n4216484\n4216553\n4216562\n4216563\n4216632\n4216648\n4216660\n4216702\n4216719\n4216720\n4216769\n4216771\n4216812\n4216847\n4216866\n4216896\n4216897\n4216900\n4216904\n4216934\n4216967\n4216974\n4217005\n4217063\n4217073\n4217077\n4217108\n4217124\n4217149\n4223464\n4223465\n4223466\n4223467\n4223468\n4223469\n4223470\n4223471\n4223472\n4223473\n4223474\n4223475\n4223476\n4223477\n4223478\n4223479\n4223480\n4223481\n4223482\n4223483\n4223484\n4223485\n4223486\n4223487\n4223488\n4223489\n4223490\n4223504\n4223505\n4223506\n4223507\n4223508\n4223509\n4223510\n4223511\n4223512\n4223513\n4223514\n4223515\n4223516\n4223517\n4207810\n4207823\n4207838\n4207856\n4207871\n4207941\n4207967\n4207981\n4207983\n4208055\n4208113\n4208126\n4208133\n4208134\n4208147\n4208175\n4208296\n4208299\n4208349\n4208380\n4208399\n4208407\n4208471\n4208491\n4208492\n4208527\n4208534\n4208549\n4208550\n4208555\n4208557\n4208600\n4208622\n4208631\n4208649\n4208652\n4208678\n4208729\n4208736\n4208761\n4208762\n4217226\n4217246\n4217256\n4217281\n4217287\n4217306\n4217309\n4217312\n4217329\n4217335\n4217349\n4217389\n4217390\n4217400\n4217423\n4217430\n4217434\n4217442\n4217451\n4217510\n4217511\n4217541\n4217542\n4217556\n4217557\n4217575\n4217579\n4217596\n4217629\n4217656\n4217660\n4217669\n4217671\n4217679\n4217703\n4217705\n4217709\n4217710\n4217760\n4217764\n4217776\n4223518\n4223529\n4223530\n4223531\n4223532\n4223533\n4223534\n4223535\n4223536\n4223537\n4223538\n4223539\n4223554\n4223555\n4223556\n4223557\n4223558\n4223559\n4223560\n4223561\n4223562\n4223563\n4223564\n4223565\n4223579\n4223580\n4223581\n4223582\n4223583\n4223584\n4223585\n4223586\n4223587\n4223588\n4223589\n4223590\n4223604\n4223605\n4223606\n4223607\n4223608\n4208792\n4208818\n4208829\n4208839\n4208854\n4208858\n4208865\n4208883\n4208903\n4208921\n4208981\n4208985\n4208999\n4209034\n4209035\n4209075\n4209095\n4209101\n4209130\n4209143\n4209157\n4209171\n4209175\n4209210\n4209222\n4209232\n4209238\n4209251\n4209265\n4209282\n4209299\n4209322\n4209327\n4209370\n4209371\n4209376\n4209421\n4209443\n4209459\n4209475\n4209511\n4217779\n4217784\n4217804\n4217808\n4217819\n4217834\n4217838\n4217874\n4217889\n4217891\n4217897\n4217903\n4217921\n4217945\n4217976\n4217978\n4217984\n4217989\n4217990\n4218004\n4218010\n4218018\n4218037\n4218040\n4218067\n4218073\n4218097\n4218104\n4218108\n4218112\n4218174\n4218179\n4218223\n4218228\n4218229\n4218239\n4218288\n4218294\n4218297\n4218323\n4218344\n4223609\n4223610\n4223611\n4223612\n4223613\n4223614\n4223615\n4223616\n4223629\n4223630\n4223631\n4223632\n4223633\n4223634\n4223635\n4223636\n4223637\n4223638\n4223639\n4223640\n4223641\n4223642\n4223643\n4223644\n4223646\n4223647\n4223648\n4223649\n4223650\n4223651\n4223652\n4223653\n4223654\n4223680\n4223681\n4223682\n4223683\n4223684\n4223685\n4223686\n4223687\n4209517\n4209549\n4209567\n4209568\n4209570\n4209598\n4209605\n4209611\n4209643\n4209667\n4209698\n4209700\n4209733\n4209737\n4223714\n4223715\n4223730\n4223731\n4223732\n4223733\n4223734\n4223735\n4223736\n4223737\n4223738\n4218545\n4218555\n4218579\n4218594\n4218598\n4218619\n4218682\n4218716\n4218802\n4218804\n4218826\n4219053\n4219087\n4219153\n4219154\n4223739\n4223740\n4223741\n4223742\n4223743\n4223744\n4223745\n4223746\n4223747\n4223748\n4223688\n4223689\n4223690\n4223691\n4223692\n4223693\n4223705\n4223706\n4223707\n4223708\n4223709\n4223710\n4223711\n4223712\n4223713\n4223749\n4223750\n4223751\n4223752\n4223753\n4223754\n4423189", "firm_fei_number": "3003070421", "recalling_firm": "Howmedica Osteonics Corp.", "address_1": "325 Corporate Dr", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2006", "reason_for_recall": "Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.", "root_cause_description": "Vendor change control", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 8/7/24 was sent to customers.\n\nRecommendations for patients treated with an impacted device:\nPatients treated with an affected product identified in Attachment 1 should continue to be followed per the normal protocol established by his or her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol.\n\nActions Needed:\nOur records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions.\n1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product.\n2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility.\n3. Quarantine and discontinue use of the recalled devices identified in the affected product list in Table 1.\n4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to\n\" Medical Facility: Please sign the Business Reply Form and email to:\nstrykerortho3291@sedgwick.com/ Fax: (800) 871-7270\n5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.\n6. Please return the devices to Stryker using the following address:\nStryker Orthopaedics/PFA Product Returns\nAttn: Distribution Inventory Team\n3365 Enterprise Avenue\nWeston, Florida, 33331\nRef. PFA 3626925(Please provide tracking number)\n\nPlease assist us in meeting our regulatory obligation by completing and emailing the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physica", "product_quantity": "897 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Germany.", "openfda": { "k_number": [ "K182104", "K223301", "K180307", "K242464", "K243560", "K192140", "K133759", "K252058", "K230087", "K163581", "K163338", "K183381", "K183644", "K223767", "K251971", "K233199", "K253381", "K202184", "K252742", "K252962", "K230880", "K250877", "K241517", "K252871", "K220255", "K214011", "K251315", "K122011", "K200791", "K170977", "K153603", "K241130", "K202749", "K211441", "K241893", "K240721", "K213873", "K233299", "K192653", "K251073", "K220459", "K093425", "K170280", "K222510", "K223558", "K182964", "K110240", "K211442", "K201189", "K121936", "K131130", "K230369", "K223351", "K212007", "K262121", "K213877", "K230243", "K250520", "K090420", "K202320", "K203115", "K220146", "K253623", "K221224", "K231229", "K152041", "K243751", "K111843", "K172849", "K252088", "K221618", "K251316", "K162567", "K162962", "K250608", "K201251", "K201006", "K193307", "K251943", "K212825", "K233706", "K181890", "K241625", "K260582", "K260329", "K110021", "K232140", "K243671", "K243514", "K172301", "K112507", "K140689", "K230195", "K172115", "K212023", "K231172", "K260369", "K240062", "K251780", "K173338", "K220973", "K151364", "K180816", "K193120", "K260011", "K090953", "K180277", "K153647", "K093118", "K211616", "K103400", "K240139", "K232044", "K202552", "K230861", "K243659", "K203291", "K140331", "K182731", "K254157", "K203005", "K233443", "K261113", "K220522", "K251060", "K220652", "K233595", "K240625", "K232800", "K220024", "K240211", "K242933", "K212028", "K173946", "K233255", "K160385", "K153237", "K233725", "K131425", "K170891", "K201327", "K102967", "K213546", "K192911", "K181596", "K191039", "K250086", "K162195", "K223070", "K252880", "K202769", "K232116", "K140454", "K252873", "K172268", "K230700", "K230989", "K221180", "K223765", "K240662", "K242890", "K170581", "K180271", "K201661", "K140927", "K111443", "K200095", "K242914", "K222698", "K172518", "K252544", "K260546", "K261060", "K232345", "K252562", "K213876", "K232413", "K253921", "K193515", "K192133", "K122326", "K203110", "K103829", "K250879", "K172517", "K212756", "K233513", "K243258", "K191012", "K242121", "K222291", "K183605", "K180038", "K192173", "K170011", "K241011", "K143668", "K252087", "K243387", "K150231", "K213033", "K242009", "K192526", "K083644", "K241031", "K100742", "K121064", "K160537", "K210668", "K233227", "K092497", "K181606", "K152574", "K253444", "K140167", "K220241", "K121765", "K192495", "K193094", "K261852", "K200719", "K143752", "K234047", "K193135", "K192336", "K090375", "K233542", "K243481", "K182982", "K171321", "K203816", "K141694", "K143597", "K191369", "K162341", "K183630", "K260240", "K142530", "K192080", "K260571", "K241171", "K233256", "K182848", "K191507", "K172166", "K190556", "K190881", "K191854", "K251282", "K261024", "K233228", "K261205", "K172623", "K172462", "K250167", "K120867", "K110204", "K212537", "K203040", "K252950", "K200892", "K231963", "K210574", "K170584", "K162937", "K180523", "K171556", "K251314", "K210457", "K170593", "K203205", "K091998", "K250182", "K213918", "K230876", "K231886", "K162364", "K083310", "K213491", "K102990", "K210472", "K220348", "K223350", "K220774", "K130748", "K232572", "K182524", "K252841", "K242864", "K170937", "K182121", "K172219", "K240160", "K212088", "K213720", "K223511", "K130387", "K261665", "K220958", "K203751", "K191285", "K200376", "K241644", "K243285", "K200935", "K210555", "K223927", "K200047", "K242806", "K153700", "K214059", "K254148", "K252989", "K140596", "K181111", "K181449", "K201255", "K241082", "K201022", "K153203", "K254158", "K220862", "K243419", "K181848", "K143628", "K173372", "K220593", "K252037", "K202836", "K162921", "K260601", "K170360", "K243326", "K162375", "K230064", "K230716", "K201966", "K153240", "K222966", "K232521", "K242264", "K192663", "K153396", "K151511", "K221028", "K100599", "K160713", "K083009", "K091411", "K213708", "K213380", "K230783", "K182721", "K163221", "K222383", "K193618", "K223649", "K124004", "K223108", "K141941", "K230202", "K093206", "K252597", "K172034", "K191998", "K253661", "K240701", "K243958", "K240951", "K130887", "K243814", "K260222", "K191100", "K163379", "K182077", "K183196", "K230180", "K201569", "K200642", "K200888", "K221928", "K182345", "K260010", "K191223", "K122742", "K240647", "K191722", "K110054", "K171267", "K231494", "K253604", "K223553", "K203561", "K190653", "K232533", "K250599", "K252755", "K100107", "K102251", "K220038", "K223808", "K191943", "K083483", "K261410", "K170430", "K203679", "K193128", "K220291", "K180352", "K212245", "K203573", "K232802", "K242373", "K233254", "K180796", "K171780", "K211596", "K240568", "K202956", "K171651", "K222355", "K111811", "K231527", "K243073", "K231184", "K141601", "K260480", "K090313", "K233638", "K141989", "K222753", "K172522", "K083872", "K210121", "K180690", "K223200", "K200845", "K171525", "K093998" ], "registration_number": [ "3030400539", "3020703621", "1225492", "1058584", "3013485140", "3017823294", "3003678543", "3006846753", "3003525643", "3016261131", "1047843", "1644408", "3009882675", "3011577940", "3033536255", "3021976927", "2135156", "1833920", "2133928", "3010822102", "3014498598", "3000719653", "3016678045", "2648623", "9611112", "3027153110", "3012447612", "1643264", "3004638600", "2011171", "3011187779", "3012639025", "3009165919", "3010047454", "3010141593", "3008868758", "3006791286", "3013552417", "3005819474", "3004608878", "3009293341", "3007521480", "3021902355", "3018565653", "3004513872", "3009973336", "9617840", "3016438694", "3038503932", "1834331", "3002907620", "2027467", "3010120339", "3006125668", "9611579", "3010049501", "3003541440", "1424263", "2133641", "3012428435", "1834379", "3013194153", "3012120772", "3010009632", "3003661942", "3012966183", "3004060780", "8010177", "3009050824", "3021008900", "2647346", "3007366790", "3009433026", "3010370554", "1824199", "3015831087", "3011656326", "3010057495", "3010041499", "2134947", "3005216725", "1221053", "9611390", "3004153896", "3012429289", "3016619943", "3006639944", "3005751028", "3016084569", "2244478", "1123169", "3010197239", "3034676720", "3015967359", "3006984710", "2953359", "3015516266", "3005677016", "3005823819", "3025343017", "3004719693", "3001592626", "8010468", "3010531060", "3040312029", "3003120897", "9611827", "3003604053", "3016496998", "1423662", "3005706667", "3009417901", "3009971621", "3008114965", "3009959868", "3009973699", "3009337690", "3009962553", "1835572", "3026576110", "3014273424", "1835251", "3012263546", "3008455034", "3017980495", "3009879967", "3015876273", "3012131184", "1045834", "1043653", "3037407500", "3006563559", "1064858", "3016090213", "1314417", "1220477", "1018470", "3009871135", "1000517406", "3010120104", "3009522766", "3005641619", "3008812560", "3010863450", "1421101", "3015907115", "3003387384", "2183449", "3017410889", "3019767615", "9616696", "3010363503", "3039520898", "1835444", "3003637761", "3011683674", "2031917", "1057425", "2133772", "2133810", "3001239363", "3043520111", "3024999441", "3010408671", "3041276509", "3010032903", "3008837339", "3019807891", "2090010", "3016050940", "8031020", "3008027912", "3014252644", "3001284227", "2246552", "3011782009", "3036756245", "3007441485", "1219602", "1928237", "3013422236", "3012911444", "1226188", "3010173425", "1625507", "3012401682", "3007700286", "9615128", "1526439", "3009493875", "3003500271", "1020279", "3010313588", "3013404959", "8043933", "1833824", "9617544", "3004024955", "3014479313", "3007014520", "3010097171", "3030154790", "9680515", "3009973505", "3010663372", "3027305794", "3003955307", "3017565094", "2031966", "1828464", "3025110439", "3004717358", "3007922509", "3019878714", "3020375573", "3004016520", "3017123055", "3010155648", "3007993775", "3015941638", "3005075696", "3009888740", "3009049161", "2087234", "3004181214", "3010120148", "3005083075", "3006776201", "3014170143", "3003596442", "1319660", "3009185973", "3006654680", "9611813", "3009051471", "1424434", "3005061536", "2027487", "1450662", "3014411622", "3005874553", "1030489", "3010009693", "3011015572", "1526534", "1226544", "3010197224", "3004499989", "2530808", "3026776", "3004188066", "2183946", "3007997036", "3008992889", "3012764194", "3013422238", "3002743211", "9614209", "3008583793", "3004893332", "3004774118", "2531477", "1221763", "3005180920", "3003761012", "1818910", "3007125392", "3010120135", "3007539489", "3015399803", "3003139373", "3011796723", "3010129044", "3004635447", "3006783837", "3008110533", "3015179588", "3003477135", "3025603301", "9612277", "3006460162", "1221485", "3002807090", "3007485169", "3021060474", "9610622", "2219920", "3007515069", "2030624", "3033536319", "1056553", "3010162973", "3005012805", "3043543260", "3015869121", "3009380063", "3009144915", "3012227716", "8010916", "3017528621", "3010041430", "3030412764", "9610612", "1828288", "3024788684", "3017406274", "3011713200", "3015542154", "3016443334", "3005739886", "3003639920", "2134470", "8043792", "9612420", "3009266751", "2031910", "3018405359", "3010287737", "3012495575", "2081135", "3010123206", "3014782362", "9617297", "2024311", "1720929", "3018094310", "3004142400", "3014680795", "3006493760", "3015537048", "3007728266", "3014725904", "3004209178", "2031093", "1649518", "1833986", "3013917867", "3003617485", "1000548922", "3009887475", "3007344102", "3040335671", "3011674645", "3006128100", "3004126422", "3003935342", "2133786", "3023852420", "3004976965", "3021632375", "1721964", "3009554293", "3004641308", "3021948057", "3013302242", "3015536273", "3004727093", "1721676", "3011795235", "3004464325", "3000270450", "3033509898", "3015877656", "3014655115", "1836357", "3013682146", "3017492965", "2249615", "3010986197", "1835296", "1723170", "3012098629", "3010039400", "3010232390", "1935627", "3005497913", "3009381600", "1319639", "3010047402", "3010462278", "3010120326", "1218017", "3009394448", "2528981", "3015207155", "3025783933", "3016075969", "1833506" ], "fei_number": [ "3030400539", "1000138054", "3020703621", "3013485140", "1000117423", "3017823294", "1000221916", "3003678543", "3006846753", "3003525643", "3016261131", "1047843", "3011764740", "3011577940", "3033536255", "3021976927", "3010822102", "3014498598", "3000719653", "3016678045", "2648623", "3027153110", "3002821504", "3012447612", "1643264", "3004638600", "2011171", "3003569173", "3011187779", "3001236549", "3012639025", "3009165919", "3010047454", "3002904345", "3010141593", "3008868758", "3006791286", "3013552417", "3005819474", "3004608878", "3009293341", "3007521480", "3021902355", "3018565653", "3004513872", "3009973336", "3016438694", "3038503932", "1832656", "3002907620", "2027467", "3010120339", "3006125668", "3010049501", "3003541440", "3008342029", "1000517638", "3002807231", "3006003617", "3010666513", "3012428435", "3013194153", "3003640911", "3012120772", "3010009632", "3003661942", "3012966183", "3004060780", "3009050824", "3021008900", "2647346", "3009433026", "3010370554", "1824199", "3015831087", "3000204692", "3010057495", "3011656326", "3005216725", "1221053", "3004153896", "3012429289", "3016619943", "3002807156", "3006639944", "3005751028", "3016084569", "3010197239", "3034676720", "3015967359", "3006984710", "3015516266", "3005677016", "1000116116", "3025343017", "3004719693", "1000219637", "3001592626", "3010531060", "3040312029", "3003120897", "3000717902", "3001452082", "3003604053", "3016496998", "3002806685", "3005706667", "3009417901", "3009971621", "3008114965", "3002795782", "3009959868", "3009973699", "3009337690", "3009962553", "3026576110", "3014273424", "3012263546", "3003112432", "3008455034", "3003200961", "3017980495", "3009879967", "3015876273", "3012131184", "3008397795", "1045834", "1043653", "3008782585", "3002807830", "3037407500", "3000203466", "3006563559", "3001503333", "3016090213", "1314417", "1000306303", "1220477", "1018470", "3009871135", "1000517406", "3010120104", "3009522766", "3005641619", "3008812560", "3010863450", "1421101", "1000136478", "3015907115", "3003387384", "3008647423", "1000115331", "2183449", "3002926812", "3002808269", "3019767615", "3010363503", "3039520898", "3000210784", "3003637761", "3011683674", "1000132370", "3001239363", "3043520111", "3000215273", "3024999441", "3010408671", "3041276509", "3010032903", "3001642380", "3008837339", "3002980729", "3019807891", "1000139987", "3016050940", "3008027912", "3014252644", "3001284227", "2246552", "3036756245", "3007441485", "1219602", "3003015552", "1928237", "3013422236", "3012911444", "1625507", "3012401682", "3007700286", "3002806725", "1526439", "3009493875", "3003500271", "1020279", "3003128516", "3010313588", "3004024955", "3003179719", "3014479313", "3007014520", "3010097171", "3030154790", "3009973505", "3010663372", "3027305794", "3003955307", "3017565094", "1828464", "3025110439", "3004717358", "3007922509", "3019878714", "3020375573", "3000206435", "3004016520", "3002807036", "3002929183", "3017123055", "3010155648", "1000306340", "3000205591", "3007993775", "3002807041", "3005075696", "3009888740", "3009049161", "3004181214", "3010120148", "3005083075", "3006776201", "3014170143", "3003596442", "3009185973", "3006654680", "3000209794", "3009256700", "3002807328", "3009051471", "3005061536", "2027487", "1450662", "3002806577", "3014411622", "3005874553", "3010009693", "3011015572", "1000116912", "1526534", "3003714383", "3010197224", "3004499989", "3004188066", "3007997036", "3008992889", "3012764194", "3013422238", "3002743211", "3004369318", "3008583793", "3004893332", "3003164255", "1221763", "3005180920", "3003761012", "1818910", "3007125392", "3010120135", "3007539489", "3015399803", "3003139373", "3005532635", "3011796723", "3010129044", "3004635447", "3008110533", "3015179588", "3003477135", "3025603301", "3006460162", "1221485", "3007485169", "3021060474", "2219920", "3007515069", "3033536319", "3005012805", "3001551180", "3043543260", "3015869121", "3009380063", "3009144915", "3012227716", "3017528621", "3010041430", "3030412764", "1828288", "1000135253", "3024788684", "3017406274", "3011713200", "3015542154", "3016443334", "3005739886", "3003639920", "3002806315", "3003064967", "3009266751", "3018405359", "3010287737", "3012495575", "2081135", "3010123206", "3014782362", "3007282753", "2024311", "3001236277", "1720929", "3018094310", "3002619595", "3004142400", "3005985723", "3014680795", "3001237338", "3006493760", "3015537048", "1000136269", "1000477302", "1000115656", "3007728266", "3014725904", "3000215205", "3013917867", "3003617485", "1000548922", "3040335671", "3009887475", "3007344102", "3001049282", "3008820440", "3011674645", "3006128100", "3004126422", "3002462840", "3003935342", "3002807421", "3002806773", "3005969827", "3023852420", "3004976965", "3021632375", "3009554293", "3004641308", "3021948057", "3013302242", "3015536273", "3004727093", "1721676", "3011795235", "3004464325", "3010938185", "3000270450", "3033509898", "3015877656", "3014655115", "1000522098", "1000123143", "3000203066", "3013682146", "3017492965", "3008599177", "3010986197", "3012098629", "3010039400", "3010232390", "1935627", "3005497913", "3009381600", "3010047402", "3010462278", "3010120326", "1218017", "3009394448", "2528981", "3015207155", "3009322142", "3025783933", "3000717687", "3016075969" ], "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ] }