{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203861", "product_res_number": "Z-0671-2024", "event_date_initiated": "2023-09-23", "event_date_posted": "2024-01-05", "recall_status": "Completed", "res_event_number": "93299", "product_code": "IQI", "product_description": "SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis\n(AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037", "code_info": "REF: 17V1030/UDI: (01)04035459407045/ Order #s 877130\t871608\t869477\t873755\t873408\t873462\t872532\t871154\t880168\t880929\t865865\t873716\t866700\t870221\t871517\t875929\t877106\t877351\t871959\t875613\t866847\t882306\t881541\t869191\t869393\t875444\t872004\t867991\t880396\t868574\t877787\t876488\t879697\t866838\t875675\t877656\t867391\t873489\t869196\t872232\t870921\t867678\t868728\t877709\t867990\t879513\t869349\t869864\t880431\t879922\t882026\t872429\t876236\t871997\t881374\t880275\t876177\t869274\t870606\t879926\t871392\t878189\t869601\t867903\t876762\t867908\t867780\t873752\t867175\t872533\t879230;\n \nREF: 17V2030/UDI: (01)04035459407038/ Order #s: 873689\t877130\t873755\t873462\t872532\t880168\t877383\t881065\t865865\t873716\t871519\t875929\t867520\t875141\t875160\t867907\t874430\t879427\t877351\t875613\t866847\t871613\t873697\t874810\t875444\t879594\t882000\t867991\t880396\t880970\t868574\t868353\t876488\t866838\t867391\t873489\t873231\t869196\t872232\t876230\t870921\t867678\t873227\t877571\t868728\t877709\t879513\t869864\t876395\t880173\t869459\t872429\t869390\t868305\t876236\t880312\t871997\t881374\t869931\t870606\t875391\t876579\t867903\t876762\t881372\t872533\t873878\t879230;\n\nRef: 17V1031/UDI: (01)04035459407069/ Order #s: 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879043\t871155\t869394\t870244\t868306\t869846\t873447\t873150\t881441\t878461\t870616\t869193\t880166\t879026\t875477\t872812\t871999\t869456\t880378\t882237\t873163\t866891\t881632\t873875\t870072\t871148\t882041\t866674\t869923\t871636\t877108\t873672\t873563\t878342\t872015\t876569\t870596\t870241\t870870\t880390\t878795\t879729\t868544\t875802\t877375\t869095\t869379\t875805\t879228\t879735\t873688\t866979\t873526\t875481\t880184\t881636\t878420\t872220\t882084\t873218\t876845\t878766\t877986\t873395\t875980\t869882;\n\nREF: 17V2032/UDI:(01)04035459407076/Order #s: 878742\t879043\t871155\t875669\t870618\t868306\t866984\t872243\t873447\t876723\t869611\t877298\t868547\t873150\t871533\t872219\t878461\t867665\t880166\t880281\t869857\t872812\t871999\t880378\t882220\t879024\t866891\t877985\t868946\t876783\t870072\t871148\t877701\t874254\t869387\t874099\t877069\t878255\t868825\t881401\t872015\t876569\t870596\t866660\t867675\t869205\t870240\t870865\t877578\t872517\t878795\t866983\t869329\t871975\t879005\t873670\t867673\t873751\t873698\t873750\t869095\t870862\t866979\t873526\t881636\t868303\t877491\t872220\t873218\t876845\t873753\t878766\t874799\t873395\t869882\t879739;\n\nREF: 17V1033/UDI: (01)04035459407106 /Order #s: 879768\t866975\t877097\t868839\t873466\t873690\t876718\t879809\t873879\t869591\t868552\t869280\t870602\t873397\t869327\t867997\t872221\t878458\t872814\t881020\t869198\t880565\t870603\t868000\t869382\t871273\t877474\t883394\t878014\t868870\t880691\t869200\t874878\t872788\t868299\t869926\t877131\t881398\t875737\t877612\t872816\t870219\t871943\t870210\t868140\t870223\t873671\t876904\t869805\t881537\t877720\t871946\t870918\t880357\t871390\t873390\t876912\t877039\t867912\t878390\t866282\t866824;\n\nREF:17V2033/UDI: (01)04035459407090/Order #s: 870990\t867910\t875146\t873690\t869883\t879812\t879809\t869591\t878290\t874221\t869613\t869637\t871639\t867390\t876464\t880418\t870600\t880262\t869191\t873392\t880034\t869382\t869082\t877787\t880242\t880257\t866851\t874731\t878002\t878006\t866982\t873708\t866673\t869445\t877131\t881398\t879883\t875737\t872816\t870219\t868543\t881046\t877846\t876568\t876904\t875059\t869805\t878989\t881537\t877720\t871946\t878170\t881016\t876203\t879235\t882033\t867758\t879983\t873241;\n\nREF:17V1035/UDI: (01)04035459414517 /Order #s: 875828\t872283\t871945\t877520;\n\nREF: 17V2035/UDI: (01)04035459414500/Order #s: 877598\t873877\t879077\t872285;\n\nREF:17V1036/UDI: (01)04035459414531/Order #s: 871151\t873211\t875154\t878812\t874332\t882211\t882220\t882227\t872002\t877102\t876353\t874436\t877407\t877650\t872952\t880160\t877588;\n\nREF:17V2036/UDI: (01)04035459414524/Order #s: 871151\t876733\t869846\t879479\t875154\t878812\t874332\t871978\t882211\t882227\t880870\t872002\t876353\t872229\t873703\t877650\t877990\t873702\t877588;\n\nREF: 17V1037/UDI:(01)04035459414555/Order #s: 881380, 878083;\n\nREF: 17V2037/UDI:(01)04035459414548/Order #s: 881380, 878083", "firm_fei_number": "1000523125", "recalling_firm": "Townsend Design", "address_1": "4615 Shepard St", "city": "Bakersfield", "state": "CA", "postal_code": "93313-2339", "additional_info_contact": "Veronica Salazar\n800-432-3466", "reason_for_recall": "Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.", "root_cause_description": "Process control", "action": "On November 7, 2023, Townsend Design (Thuasne USA), issued a \"Urgent Medical Device Recall notification to affected consignees: Townsend Design asked consignees to take the following actions:\n\n1. Clinician should contact any patient who was fit with a device received between June\n14th and September 10, 2023 to notify them of the recall and schedule a visit to\nexamine the patient's device. \n\n2. During the patient visit, the clinician should examine the device for structural\ndefects (delamination, cracking, complete breakage, etc.) in the area identified in the\npicture above in Section 3\n\n3. If the device is observed with a defect, patient should immediately discontinue use\nof the device and it should be returned to Townsend Design (Thuasne USA)\n\n4. Clinician can contact Townsend Design (Thuasne USA) Customer Service at\n800-432-3466 for return and replacement instructions\n\n5. Townsend Design (Thuasne USA) will either refund or replace the product\n\n6. Clinician to complete and return the attached Acknowledgement and Receipt Form\nwithin 5 working days", "product_quantity": "898 units", "distribution_pattern": "US: AL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tIA\tID\tIL\tIN\tKENT\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tQC\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV\tWY, Puerto Rico, \nOUS: None\nOUS: Canada, New Zealand, Japan, Australia, Netherlands, United Kingdom", "openfda": { "k_number": [ "K811456", "K810288", "K823812", "K823113", "K811690", "K821704", "K760002", "K823160", "K822022", "K791266", "K811343", "K831615", "K811490", "K780225", "K780053", "K821582", "K822767", "K802871", "K811035", "K800715", "K802908", "K791267", "K823114", "K821641", "K802910", "K781206", "K143458", "K791565", "K810443", "K926391", "K771676", "K874502", "K761312", "K052771", "K760950", "K910974", "K801708", "K802909", "K770167", "K801788", "K821640", "K831542", "K791249", "K770612", "K791057", "K780979", 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