{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215013", "product_res_number": "Z-2461-2025", "event_date_initiated": "2025-07-17", "event_date_posted": "2025-08-27", "recall_status": "Open, Classified", "res_event_number": "97266", "product_code": "HBE", "k_numbers": [ "K111520" ], "product_description": "IPC Powerease System REF 2300000\nUDI-DI:\n00613994448705\n00643169406834.\n\nThe IPC POWEREASE System is indicated for drilling, tapping, and driving\nscrews and working end attachments during spinal surgery, including\nopen and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and\nrods. The IPC is indicated for the incision/cutting, removal, drilling, and\nsawing of soft and hard tissue and bone, and biomaterials in\nNeurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal,\nSternotomy, and General surgical procedures.", "code_info": "Product Number/Catalog: 230000\nUDI-DI code: 00613994448705\nSerial/Lot Numbers:\nPEU21207\nPEU21208\nPEU21210\nPEU21211\nPEU21212\nPEU21213\nPEU21214\nPEU21215\nPEU21216\nPEU21217\nPEU21218\nPEU21219\nPEU21221\nPEU21222\nPEU21224\nPEU21225\nPEU21226\nPEU21227\nPEU21228\nPEU21229\nPEU21230\nPEU21231\nPEU21239\nPEU21240\nPEU21246\nPEU21247\nPEU21248\nPEU21251\nPEU21252\nPEU21253\nPEU21254\nPEU21255\nPEU21257\nPEU21259\nPEU21263\nPEU21264\nPEU21265\nPEU21266\nPEU21267\nPEU21268\nPEU21269\nPEU21270\nPEU21273\nPEU21274\nPEU21277\nPEU21278\nPEU21279\nPEU21285\nPEU21286\nPEU21294\nPEU21296\nPEU21297\nPEU21299\nPEU21301\nPEU21302\nPEU21305\nPEU23001\nPEU23003\nPEU23004\nPEU23005\nPEU23009\nPEU23010\nPEU23013\nPEU23015\nPEU23016\nPEU23024\nPEU23027\nPEU23031\nPEU23044\nPEU23049\nPEU23050\nPEU23051\nPEU23052\nPEU23053\nPEU23054\nPEU23055\nPEU23056\nPEU23057\nPEU23058\nPEU23059\nPEU23060\nPEU23061\nPEU23062\nPEU23063\nPEU23064\nPEU23071\nPEU23072\nPEU23073\nPEU23074\nPEU23075\nPEU23076\nPEU23077\nPEU23078\nPEU23079\nPEU23080\nPEU23083\nPEU23086\nPEU23087\nPEU23088\nPEU23089\nPEU23098\nPEU23099\nPEU23100\nPEU23101\nPEU23105\nPEU23106\nPEU23107\nPEU23108\nPEU23109\nPEU23110\nPEU23111\nPEU23112\nPEU23125\nPEU23126\nPEU23127\nPEU23133\nPEU23134\nPEU23135\nPEU23136\nPEU23140\nPEU23142\nPEU23143\nPEU23146\nPEU23149\nPEU23159\nPEU23160\nPEU23161\nPEU23163\nPEU23164\nPEU23165\nPEU23166\nPEU23167\nPEU23170\nPEU23171\nPEU23172\nPEU23175\nPEU23176\nPEU23177\nPEU23178\nPEU23179\nPEU23180\nPEU23181\nPEU23182\nPEU23183\nPEU23196\nPEU23197\nPEU23198\nPEU23199\nPEU23207\nPEU23208\nPEU23210\nPEU23215\nPEU23216\nPEU23218\nPEU23220\nPEU23221\nPEU23222\nPEU23223\nPEU23224\nPEU23225\nPEU23229\nPEU23230\nPEU23231\nPEU23235\nPEU23249\nPEU23251\nPEU23253\nPEU23268\nPEU23277\nPEU23278\nPEU23281\nPEU23282\nPEU23283\nPEU23288\nPEU23289\nPEU23291\nPEU23292\nPEU23293\nPEU23303\nPEU23304\nPEU23305\nPEU23306\nPEU23310\nPEU23311\nPEU23312\nPEU23313\nPEU23314\nPEU23316\nPEU23317\nPEU23318\nPEU23319\nPEU23322\nPEU23323\nPEU23324\nPEU23325\nPEU23326\nPEU23327\nPEU23338\nPEU23339\n\nUDI-DI code: 00643169406834\nSerial/Lot Numbers:\nPEU23011\nPEU23012\nPEU23066\nPEU23067\nPEU23069\nPEU23137\nPEU23138\nPEU23139\nPEU23147\nPEU23173\nPEU23174\nPEU23274\nPEU23276\nPEU23279\nPEU23280", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr N", "city": "Jacksonville", "state": "FL", "postal_code": "32216-6218", "additional_info_contact": "Rita Greenberg\n904-296-9600", "reason_for_recall": "Due to out of the box wobble of the driver.", "root_cause_description": "Process change control", "action": "On 07/17/2025, the firm initiated distribution of \"URGENT: MEDICAL DEVICE RECALL\" Letters via email and/or mail to customers informing them of reported out-of-box failures due to device wobble which is due to misalignment between the quick connect and shaft main driver components of the IPC Powerease System Model 2300000.\n\nCustomers are instructed to:\n . Identify, segregate, quarantine and stop use of any affected products within your inventory. The list of affected device serial numbers is included in Attachment A: Product Serial Number List.\n. Your Medtronic field representative will coordinate the replacement of your affected product.\n. Return affected product in your inventory to Medtronic. Please see Customer Confirmation Form for instructions on returning impacted devices.\n. Please complete and return the customer confirmation form enclosed with this letter\nacknowledging receipt of this information via email to neuro.quality@medtronic.com even if you no longer have possession, custody, or control over the affected product.\nNote: Instructions on returning the acknowledgement form to Medtronic is located on the form itself.\n. Please share this communication within your organization, with other organizations where\nimpacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for your records.\n\nFor questions or assistance please contact Medtronic Sales Representative and/or Technical Services at 1-888-826-5603.", "product_quantity": "214", "distribution_pattern": "U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX, \n\nO.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom", "openfda": { "k_number": [ "K251433", "K113476", "K230619", "K930229", "K172709", "K032303", "K984035", "K191049", "K070876", "K170442", "K121264", "K162542", "K153519", "K213072", "K880601", "K062842", "K111520", "K030172", "K253627", "K143399", "K130755", "K213208", "K210377", "K050628", "K161704", "K190172", "K191479", "K250815", "K903664", "K911812", "K002903", "K900388", "K250374", "K014060", "K223199", "K902703", "K232684", "K143320", "K213454", "K072315", "K182436", "K080802", "K132436", "K022942", "K252060", "K873692", "K183545", "K183203", "K935861", "K943541", "K123270", "K875224", "K252662", "K911819", "K905097", "K042783", "K081475", "K182527", "K881418", "K202120", "K922299", "K250380", "K040076", "K203739", "K143540" ], "device_name": "Drills, Burrs, Trephines & Accessories (Simple, Powered)", "medical_specialty_description": "Neurology", "regulation_number": "882.4310", "device_class": "2", "registration_number": [ "1720929", "3001592626", "3016678045", "1824199", "3015882686", "3025764223", "1833986", "3012494290", "3003800209", "3009973505", "2134947", "1649518", "2183456", "3016577622", "1047843", "3009732568", "2953359", "1045834", "9612501", "3040335671", "3003120897", "3009973336", "3005282635", "3010375018", "3008812560", "1045254", "3038472982", "3034676720", "8030965", "3030446844", "1048735", "3036756245", "3006128100", "8031020", "1723170", "8010468", "3005382983", "1836161", "8043933", "3030733800", "3011577940", "3005067367", "3010097171", "3033536319", "8010177", "1835251", "2916714", "9616696", "3015212339", "3001239363", "1828288", "3010659131", "2183744", "3014725904", "1061124", "9680741", "3003933619", "1032347", "1836357", "3015440604", "3015967359", "3015151147", "3025603301", "3009417901", "2650143", "3005562917", "3007031059", "8044015", "3005706667", "3017210488", "2025102", "3033509898", "8043792", "3010155648", "3010363503", "2648623", "3030956508", "2027754", "1319639", "3028006458", "3010041499", "9614948", "1058584", "2133641", "8030607", "3004464325", "1834331", "3029300352", "3009970070", "9610612", "1030489", "3016438694", "1220477", "1226544", "1835444", "3013557562", "2648666", "3014334038", "3015399803", "3010591625", "1825034", "1526534", "3002806603", "3026776", "1450662", "3010173425", "3008868758", "3011300255", "8010516", "3003418325", "3014252644", "2011171", "3015453963", "3009380063", "3021632375", "3002807314", "2246552", "9681479", "3017521423", "1220724", 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