{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 974 } }, "results": [ { "cfres_id": "196076", "product_res_number": "Z-0007-2023", "event_date_initiated": "2022-08-25", "event_date_posted": "2022-10-05", "recall_status": "Open, Classified", "res_event_number": "90858", "product_code": "OQI", "k_numbers": [ "K121874" ], "product_description": "G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty", "code_info": "Item No. 010000663\nUDI-DI: 00880304524224\nLots: 7286477\n7289929\n7296576\n7296633\n7301697\n\nExp. 21-Jul-32\n\nItem No. 010000667\nUDI-DI: 00880304524262\nLot: 7253325\n\nExp. 13-Jun-32", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer, Inc.", "address_1": "1800 W Center St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2304", "additional_info_contact": "Customer Service\n574-267-6131", "reason_for_recall": "The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.", "root_cause_description": "Under Investigation by firm", "action": "On August 25, 2022, the firm notified affected customers via Urgent Medical Device Recall letters.\n\nCustomers were instructed to quarantine all affected product. Zimmer Biomet sales representatives will remove the affected product from customer facilities.\n\nCustomers should ensure that affected personnel are aware of the recall, and also notify any recipients if the product has been further distributed.\n\nIf you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.", "product_quantity": "56 US", "distribution_pattern": "Domestic distribution US nationwide.", "openfda": { "k_number": [ "K173583", "K252451", "K111481", "K172833", "K192989" ], "registration_number": [ "1038671", "3020155054", "1220477", "3013055499", "2244478", "3014302784", "3002807310", "3010047454", "1649518", "3009732568", "3015542154", "1450662", "9610612", "3002807315", "2030624", "3010173425", "3010531069", "1531174", "2528981", "1833506", "3002807090", "3043543260", "3033509898", "1828464", "1226544", "1835251", "1645151", "3011683674", "3008102042", "1721676", "3010536692", "3010120135", "1530390", "3015207155", "1423662", "3010386387", "3026776", "3002498892", "3004748528", "1529009", "3008262872", "3030412764", "1057425", "8043792", "2648920", "3016778562", "3007311878", "1834379", "3003761012", "3004153896", "1526534", "9614209", "9681642", "3013176080", "3002808022", "3010057495", "3006801265", "9681465", "3012523063", "3013413393", "1822565", "3009959868", "3020282716", "2246552", "1047843", "3005061536", "3006001176", "3009760038", "1825034", "1424263", "8044172", "3010155661", "3002806535", "3014763043", "3012725451", "3000264985", "3015398319", "2032521", "3005360851", "3013194153", "3012319330", "3010178296", "3003541440", "3004142400", "3007353762", "3012329926", "3009871135", "3025603301", "3011189525", "3036756245", "3007923096", "3035366890", "9613350", "1526711", "3001278222" ], "fei_number": [ "1038671", "3001236277", "3020155054", "1220477", "3003015552", "3013055499", "3014302784", "3002807310", "3010047454", "3009732568", "3015542154", "1450662", "3002807315", "1000220733", "1000395711", "3010531069", "1000149660", "2528981", "3007932279", "3005233524", "3043543260", "1832656", "3033509898", "1828464", "3011683674", "3002993297", "3002806653", "1721676", "1000118610", "1000135253", "3010536692", "3010120135", "1000306303", "3015207155", "3010386387", "3002498892", "3000215273", "3004748528", "1000221916", "3008262872", "3030412764", "3006003617", "3016778562", "3007311878", "3003761012", "3004153896", "1526534", "3013176080", "3002808022", "3010057495", "3006801265", "3002924544", "3003574398", "3000205591", "3012523063", "3003128516", "3000215103", "3013413393", "3009959868", "3020282716", "2246552", "3002806315", "1047843", "3005061536", "3006001176", "3009760038", "3002808269", "1825034", "3010155661", "3002806535", "3014763043", "3012725451", "3000264985", "3005360851", "3013194153", "3012319330", "3003541440", "3002807036", "3004142400", "3007353762", "3002807113", "3012329926", "3009871135", "3025603301", "3011189525", "3036756245", "3007923096", "1000136269", "3002806725", "3035366890", "1000132037", "1526711", "3001278222", "3000206435", "3003110073" ], "device_name": "Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3353", "device_class": "2" } } ] }