{ "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": 1 } }, "results": [ { "cfres_id": "105423", "product_res_number": "Z-0417-2012", "event_date_initiated": "2011-11-01", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-09-10", "res_event_number": "60447", "product_code": "KRO", "k_numbers": [ "K002757" ], "product_description": "OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY.\n\nHip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.", "code_info": "Item: 150368; Lot 081650", "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": "574-267-6639 Ext. 1676", "reason_for_recall": "Biomet has initiated this action following an investigation which identified that Part 150367, (OSS\nCemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem\n14x150).", "root_cause_description": "Mixed-up of materials/components", "action": "Biomet, Inc. sent an \"URGENT MEDICAL DEVICE RECALL NOTICE\" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.", "product_quantity": "3 units & 1 pending release", "distribution_pattern": "Distributed only in The Netherlands.", "openfda": { "k_number": [ "K910596", "K172347", "K023667", "K896048", "K070978", "K010774", "K945028", "K001548", "K122015", "K023087", "K821340", "K192798", "K223528", "K190181", "K823420", "K223069", "K133152", "K211768", "K143179", "K251665", "K140509", "K240043", "K021714", "K031804", "K021489", "K091453", "K110940", "K781971", "K062301", "K013031", "K013035", "K120992", "K013385", "K140900", "K972401", "K072367", "K161520", "K130299", "K052685", "K211677", "K810520", "K820995", "K041352", "K081111", "K261898", "K230563", "K252303", "K060131", "K001957", "K083827", "K121029", "K220628", "K910877", "K013340", "K821476", "K051479", "K191779", "K230416", "K011810", "K190100", "K811105", "K083779", "K021260", "K060360", "K101815", "K233980", "K152431", "K140898", "K242871", "K982160", "K131393", "K003504", "K020381", "K163311", "K031480", "K080330", "K823115", "K994207", "K051570", "K151118", "K002552", "K151008", "K040749", "K150028", "K092138", "K252898", "K210010" ], "registration_number": [ "3012755988", "1220477", "3010065126", "1225675", "3007539489", "3010163695", "3013055499", "2244478", "3014302784", "3002807310", "3009732568", "3015542154", "1450662", "9610612", "3003639920", "3002807315", "1000517406", "3010173425", "9613369", "1531174", "2528981", "3011187779", "3008110533", "3011295718", "3011061242", "3005562917", "2249697", "3002907620", "3033509898", "1828464", "3008421730", "2245304", "3006017180", "3008281151", "1835251", "1645151", "3011683674", "1721676", "3010536692", "3020703621", "9611390", "3004196040", "1218882", "3009923578", "3001284227", "3015207155", "1834331", "1833986", "3003387384", "3004635447", "1423662", "3010386387", "3029890418", "3010009693", "3010041993", "3010288357", "3004748528", "1529009", "3016438694", "3007963827", "3010097171", "3021008900", "1057425", "8043792", "2648920", "9616671", "3013450937", "3008868758", "1834379", "3009973336", "3004153896", "1526534", "9681642", "3013176080", "2183946", "3002808022", "3010057495", "3006801265", "3005180920", "2133928", "3014680795", "1833920", "3008556682", "9681465", "3004513872", "9610726", "3011015572", "3010220595", "3015516266", "3007856226", "1822565", "3009973505", "2246552", "3005551626", "1047843", "3005061536", "3009760038", "3010039400", "1825034", "1424263", "3009813841", "3038503932", "1827096", "1000550978", "9616680", "1219655", "3005751028", "3012725451", "3000264985", "3007189546", "3009882462", "3006395932", "2134285", "1020279", "3007366790", "9610622", "2249615", "9616944", "1422549", "3004371426", "3012329926", "3009173317", "3009888740", "3025603301", "3036756245", "3022142628", "1000200989", "3007923096", "1643264", "1818910", "3014252644", "3010132111", "3035366890", "3036773273", "3006946276", "1836357", "3009848551" ], "fei_number": [ "3012755988", "1220477", "3010065126", "3003015552", "3007539489", "3010163695", "3013055499", "1000139987", "3014302784", "3002807310", "3007282753", "3009732568", "3015542154", "1450662", "3003639920", "3002807315", "1000220733", "1000395711", "1000517406", "3002807172", "1000149660", "2528981", "3011187779", "3008110533", "3011295718", "3011061242", "3005562917", "3002907620", "3002806773", "3033509898", "1828464", "3008421730", "2245304", "3006017180", "3008281151", "3011683674", "3002993297", "1721676", "1000118610", "3010536692", "3020703621", "3004196040", "1218882", "1000306303", "3009923578", "3001284227", "3015207155", "3004635447", "3003387384", "3010386387", "3029890418", "3010009693", "3010041993", "3010288357", "3000215273", "3004748528", "3001451451", "1000221916", "3016438694", "3007963827", "3010097171", "3021008900", "3003070421", "3001049282", "3013450937", "3008868758", "1000116116", "3009973336", "3002807231", "3004153896", "1526534", "3013176080", "3003064967", "3002808022", "3010057495", "1000306340", "3006801265", "3005180920", "3014680795", "3008556682", "3000205591", "3004513872", "3011015572", "3010220595", "3015516266", "3007856226", "3009973505", "2246552", "3005551626", "3002806315", "1047843", "3005061536", "3002287318", "3009760038", "1000115656", "3010039400", "3002808269", "3002854251", "1825034", "3009813841", "3038503932", "1827096", "3002807893", "1000550978", "1219655", "3005751028", "3012725451", "3002459190", "3000264985", "3007189546", "3009882462", "3006395932", "1020279", "3003414678", "3002807036", "3002807113", "1000159999", "3012329926", "3009173317", "3009888740", "3025603301", "3003386935", "3036756245", "3022142628", "1000200989", "3007923096", "3000717902", "1643264", "1000136269", "3014252644", "3010132111", "1818910", "3035366890", "1000132037", "3036773273", "3006946276", "3009848551" ], "device_name": "Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3510", "device_class": "2" } } ] }