{ "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": "143462", "product_res_number": "Z-0850-2016", "event_date_initiated": "2016-01-11", "event_date_posted": "2016-02-22", "recall_status": "Terminated", "event_date_terminated": "2017-05-23", "res_event_number": "73142", "product_code": "KWA", "k_numbers": [ "K091973" ], "product_description": "Metasul Head 40, 12/14, SZ M/0\ntotal hip prosthesis - metal femoral heads\nNoninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty.\"", "code_info": "Item number: 00-8770-040-02 Lots: 2564467 2573371 2625382 2631721 2655075 2655076 2685143", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "1800 W Center St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2304", "additional_info_contact": "Consumer Relations Call Center\n800-447-5633", "reason_for_recall": "LDPE bag containing the implant adheres to the highly polished implant surface.", "root_cause_description": "Process control", "action": "Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. \nCustomers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.\nFor questions regarding this recall call 800-447-5633.", "product_quantity": "194", "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to \nARGENTINA \nAUSTRALIA\nAUSTRIA\nBARBADOS\nBELGIUM\nBERMUDA\nBOLIVIA\nBRAZIL\nCARIBBEAN\nCHILE\nCHINA\nCOLOMBIA\nCOST RICA\nDENMARK\nDOMINICAN REPUBLIC\nDORAL FL\nECUADOR\nEL SALVADOR\nENGLAND\nFRANCE\nGERMANY\nGUATEMALA\nHONDURAS\nHONG KONG\nINDIA\nISRAEL\nITALY\nJAMAICA\nJAPAN\nKOREA\nMALAYSIA\nMEXICO\nNEW ZEALAND\nNICARAGUA\nPANAMA\nPERU\nSINGAPORE\nSPAIN\nSWEDEN\nSWITZERLAND\nTAIWAN\nTHAILAND\nVENEZUELA\nWEST INDIES\nCanary Islands\nCroatia\nCyprus\nCzech Republic\nCanada", "openfda": { "k_number": [ "K071723", "K121544", "K052888", "K053588", "K021349", "K842518", "K895157", "K861723", "K090757", "K043073", "K113322", "K081007", "K033634", "K852351", "K073637", "K071856", "K062998", "K062995", "K083651", "K082924", "K063251", "K011110", "K023786", "K043099", "K922868", "K974728", "K101475", "K031963", "K112150", "K850773", "K122778", "K070274", "K871453", "K062994", "K082585", "K902111", "K001536", "K063414", "K061221", "K993438", "K092331", "K111699", "K842466", "K070221", "K001523", "K993569", "K063002", "K843940", "K053536", "K042037", "K052915", "K002883", "K080991", "K003250", "K041425", "K081090", "K063614", "K882675", "K885049", "K872985", "K093235", "K112080", "K042530", "K103755", "K851404", "K091423", "K080663", "K062426", "K850766", "K851213", "K070359", "K113271", "K091003", "K060358", "K052320", "K110399", "K882671", "K082446", "K101086", "K780330", "K852699", "K864515", "K113019", "K872768", "K870923", "K871956", "K073413", "K060356", "K843950", "K850840", "K003758", "K043547", "K100469", "K110029", "K902110", "K050124", "K110400", "K850055", "K844943", "K901626", "K040354", "K870924", "K061423", "K111698", "K040627", "K033943", "K110836", "K003523", "K111910", "K050251", "K083642", "K002379", "K091973", "K102565" ], "registration_number": [ "3002806535", "2245304", "3006809628", "1818910", "1529009", "1526534", "8010379", "3012392319", "3008021110", "3010057495", "3008421730", "3002807315", "3012119238", "1822565", "9681465", "3010536692", "3011683674", "3004153896", "3013055499", "3007740680", "1047843", "9613350", "3006801265", "1644408", "1721676", "9614209", "3015542154", "2249697", "1649518", "1828464", "3008868758", "3013176080", "3010386387", "1825034", "3035366890", "3004748528", "3003595343", "3014302784", "3005061536", "3002806603", "8043792", "1450662", "3006536454", "3006946279", "3007923096", "3014315560", "9616671", "3012725451", "3008262872", "3002807310", "3015207155", "1221763", "3006128100", "3026771806" ], "fei_number": [ "3002808269", "1000116912", "3002806535", "2245304", "3006809628", "1818910", "1526534", "3012392319", "3001236277", "3008021110", "3010057495", "3008421730", "3005233524", "3002807315", "3012119238", "1000220733", "3010536692", "3011683674", "3004153896", "3013055499", "3007740680", "1047843", "3006801265", "1721676", "1000199976", "3015542154", "1828464", "3002807113", "3008868758", "3013176080", "3010386387", "1825034", "3035366890", "3004748528", "3003595343", "3002854251", "3014302784", "3005061536", "3002806603", "3002806725", "3003070421", "1000149660", "1450662", "3006536454", "3006946279", "3007923096", "3014315560", "3012725451", "3008262872", "3002807310", "3015207155", "1221763", "3006128100", "3026771806" ], "device_name": "Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3330", "device_class": "3" } } ] }