{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114365", "product_res_number": "Z-0415-2013", "event_date_initiated": "2012-10-04", "event_date_posted": "2012-11-21", "recall_status": "Terminated", "event_date_terminated": "2013-03-18", "res_event_number": "63613", "product_code": "KWA", "k_numbers": [ "K050124" ], "product_description": "Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. \n\nIntended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered", "code_info": "Part 11-106054 Lot 528310", "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": "Audrey Daenzer\n574-267-6639 Ext. 1676", "reason_for_recall": "The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)", "root_cause_description": "Labeling Change Control", "action": "BIOMET called distributors who received the affected product to return it to Biomet with follow-up Urgent Recall Notices sent via E-mail October 22, 2012.. The notice included the identity of the recalled device, reason for the recall, and directions to complete the FAX back form and return it to 574-372-1683. Product is to be returned to Return Goods, Recalls, Biomet, Inc.\n56 East Bell Drive, Warsaw, IN 46580. Questions related to the recall should be directed to Field Action Coordinator (574) 372-1570, Monday through Friday. 8 a.m. to 5 p.m.\nFor questions regarding this recall call 574-267-6639, ext 1676.", "product_quantity": "16 (5 USA)", "distribution_pattern": "Nationwide Distribution including CA, IN, NC, OH, and UT.", "openfda": { "k_number": [ "K851404", "K063614", "K113271", "K043073", "K871453", "K850840", "K101475", "K061221", "K852699", "K052320", "K060358", "K102565", "K113019", "K053588", "K003523", "K902110", "K080663", "K003250", "K895157", "K062426", "K073637", "K062994", "K033943", "K843940", "K043547", "K052888", "K061423", "K100469", "K050124", "K861723", "K063002", "K864515", "K002883", "K922868", "K070221", "K080991", "K111910", "K843950", "K060356", "K842466", "K091003", "K974728", "K110836", "K042037", "K062998", "K112150", "K110399", "K882671", "K073413", "K851213", "K082924", "K993438", "K091973", "K043099", "K052915", "K042530", "K081007", "K063251", "K050251", "K122778", "K110029", "K083642", "K011110", "K110400", "K112080", "K842518", "K850055", "K053536", "K021349", "K091423", "K001536", "K103755", "K872768", "K031963", "K870924", "K993569", "K002379", "K113322", "K062995", "K093235", "K070274", "K071723", "K885049", "K003758", "K872985", "K852351", "K111699", "K092331", "K071856", "K844943", "K082446", "K850766", "K063414", "K871956", "K070359", "K040627", "K780330", "K850773", "K082585", "K081090", "K111698", "K001523", "K901626", "K902111", "K041425", "K083651", "K882675", "K870923", "K101086", "K121544", "K033634", "K090757", "K040354", "K023786" ], "registration_number": [ "3010386387", "3004748528", "3008868758", "3026771806", "1526534", "1047843", "2245304", "3002807315", "3005061536", "3010536692", "1818910", "8010379", "9614209", "3014315560", "1828464", "3006946279", "3035366890", "3007923096", "1529009", "1221763", "9616671", "3006536454", "3008421730", "3015542154", "3012392319", "3013055499", "3012725451", "3012119238", "9613350", "9681465", "3014302784", "1822565", "3007740680", "3004153896", "8043792", "3006801265", "3010057495", "1450662", "3006128100", "3013176080", "3002807310", "3011683674", "3003595343", "1825034", "3002806535", "3008021110", "3008262872", "1644408", "3015207155", "3006809628", "2249697", "1721676", "3002806603", "1649518" ], "fei_number": [ "3010386387", "3002807113", "3004748528", "3008868758", "3026771806", "1526534", "1000199976", "1047843", "3001236277", "3003070421", "2245304", "3002854251", "3002807315", "3005061536", "3010536692", "1818910", "3014315560", "1828464", "3002808269", "3005233524", "3006946279", "3035366890", "3007923096", "1221763", "3006536454", "3002806725", "1000149660", "3008421730", "3015542154", "3012392319", "3013055499", "3012725451", "3012119238", "3014302784", "1000116912", "3007740680", "3004153896", "3006801265", "3010057495", "1450662", "3006128100", "3013176080", "3002807310", "3011683674", "3003595343", "1825034", "3002806535", "3008021110", "3008262872", "3015207155", "3006809628", "1721676", "3002806603", "1000220733" ], "device_name": "Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3330", "device_class": "3" } } ] }