{ "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": "183727", "product_res_number": "Z-0097-2021", "event_date_initiated": "2020-09-03", "event_date_posted": "2020-10-09", "recall_status": "Terminated", "event_date_terminated": "2022-12-20", "res_event_number": "86382", "product_code": "JDI", "k_numbers": [ "K051569" ], "product_description": "(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: \nAcetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: \nItem No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930\n\n(2) RingLoc Hip system Acetabular Bi-Polar Cup: \nAcetabular Cup, ArCom, 41 MM OD, 28 MM ID:\nItem No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750\n\n(3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:\nAcetabular Cup, ArCom, 52 MM OD, 28 MM ID: \nItem No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290", "code_info": "(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:  Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM:  Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930; EXP Date June 14th 2023  (2) RingLoc Hip system Acetabular Bi-Polar Cup:  Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750; EXP Date June 14th 2023  (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID:  Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290; EXP Date June 12th 2023", "firm_fei_number": "1825034", "recalling_firm": "Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-6989", "additional_info_contact": "Kevin W. Escapule\n574-372-4487", "reason_for_recall": "Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.", "root_cause_description": "Process control", "action": "All affected customers were sent a letter on 09/03/2020 stating the following : Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.\n\nZimmer Biomet will follow up w/ consignees that have not responded after the initial notification. Additional notifications via telephone, fax, email, or traceable carrier will be sent to those who have not completed the required certification form or provided surgeon and hospital information/confirmation. 100% of the delivery notifications will be accounted for.\n\nAn inventory return certification form will be returned from each distributor that certifies that all available products from their territory have been returned or accounted for. Affected products that are not returned or accounted for will be considered as \"not in inventory and unavailable for return.\"\n\nZimmer Biomet will deem accounts unresponsive after 3 effectiveness checks if there continues to be no response are making reasonable efforts. Product that has not been recovered rom unresponsive consignees will be reported as unaccounted for. \n\nProduct returned from the field will be scrapped.", "product_quantity": "48 devices", "distribution_pattern": "Devices were distributed nationwide throughout the United States and to locations OUS. There has been one unit returned prior to the recall and approximately 14 units that have been previously implanted, leaving 33 units in the field subject to removal.", "openfda": { "k_number": [ "K936214", "K051335", "K901240", "K872732", "K936127", "K880390", "K911052", "K963109", "K925348", "K912426", "K823728", "K855200", "K923898", "K042959", "K903116", "K905298", "K900257", "K921383", "K983136", "K030153", "K973809", "K881128", "K922733", "K034028", "K934857", "K001733", "K895636", "K210842", "K874616", "K854046", "K922862", "K980486", "K884888", "K090998", "K803074", "K070364", "K972460", "K823729", "K960425", "K896851", "K913812", "K991538", "K093646", "K153057", "K844050", "K924323", "K910988", "K925201", "K902727", "K002757", "K960151", "K930275", "K873626", "K861988", "K990032", "K222056", "K901087", "K972641", "K844319", "K873999", "K960658", "K840357", "K871401", "K910869", "K952629", "K904844", "K871857", "K901297", "K870216", "K001759", "K882869", "K890498", "K841391", 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"1221053", "3010536692", "3010039400", "3004153896", "3010220595", "3004635447", "3010132111", "2246552", "3020282716", "3014252644", "3007740680", "3008110533", "3036756245", "3005751028", "3003015552", "3025603301", "3000196378", "3010288357", "3002807113", "3013176080", "3035366890", "3002807038", "3003070421", "3002806603", "3009106092", "3002806725", "3014763043", "3001278222", "3043543260", "3002459190", "3006017180", "2528981", "3002807310", "3015207155", "3015516266", "3006085220", "3013450937" ], "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3350", "device_class": "2" } } ] }