{ "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": "34580", "product_res_number": "Z-0305-05", "event_date_initiated": "2004-06-21", "event_date_posted": "2004-12-14", "recall_status": "Terminated", "event_date_terminated": "2006-02-15", "res_event_number": "29816", "product_code": "KRO", "k_numbers": [ "K912735" ], "product_description": "Tibial Base Plates", "code_info": "Tibial Base Plates 726100, 726101, 727100, 727101, 726202, 726203, 727202, 727203, 726304, 726305, 727304, 727305", "firm_fei_number": "1020279", "recalling_firm": "Smith & Nephew Inc", "address_1": "1450 E Brooks Rd", "city": "Memphis", "state": "TN", "postal_code": "38116-1804", "additional_info_contact": "R. Gordon Howe\n901-399-5563", "reason_for_recall": "The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.", "root_cause_description": "Other", "action": "Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.", "product_quantity": "11,339 units were distributed", "distribution_pattern": "Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel.", "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" } } ] }