{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "181431", "product_res_number": "Z-2331-2020", "event_date_initiated": "2020-04-22", "event_date_created": "2020-06-09", "recall_status": "Open, Classified", "res_event_number": "85637", "product_code": "MBL", "k_numbers": [ "K070756" ], "product_description": "smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:\nSize\tREF/product number \n42MM\t71331842\n48MM\t71331848\n50MM\t71331850\n52MM\t71331852\n54MM\t71331854\n56MM\t71331856\n58MM\t71331858\n60MM\t71331860\nOrthopedic implant component.", "code_info": "71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572   71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829   71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A    71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A  71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM08695, 18MM08697, 18MM08724, 19AM17823, 19AM17833, 19AM17837, 19AM17845, 18MM08650A, 18MM08663A, 19AM17845A, 19AM17833A, 19AM17837A  71331856, Lot Numbers: 18JM15947, 18MM12475, 18JM15950, 18KM04251, 18HM19101, 18JM15940, 18KM04254, 18HM19123, 18KM15773, 18JM15949, 18JM15949A, 18LM18546, 18HM19116, 18HM19117, 18JM15941, 18KM04226, 18KM04250, 18KM04252, 18KM04253, 18KM13646, 18KM17025, 18KM17026, 18KM17029, 18KM17031, 18KM17032, 18LM18544, 18LM18550, 18MM12424, 18MM12426, 18MM12428, 18MM15587, 18MM15611, 18LM05390, 18KM17031A, 18LM18550A    71331858, Lot Numbers: 19AM03504, 19AM03511   71331860, Lot Numbers: 18JM10154, 18JM10154A", "firm_fei_number": "1020279", "recalling_firm": "Smith & Nephew, Inc.", "address_1": "1450 E Brooks Rd", "city": "Memphis", "state": "TN", "postal_code": "38116-1804", "reason_for_recall": "A manufacturing error resulted in out of specification R3 Acetabular Shells", "root_cause_description": "Process control", "action": "The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew.\n\nQuestions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com.", "product_quantity": "1267 devices", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K070756", "K122382", "K201701", "K061253", "K092386", "K093363", "K960094", "K182535", "K161233", "K102370", "K201157", "K931107", "K113848" ], "registration_number": [ "3031800723", "3016778562", "3009173317", "3010041693", "3009546990", "1057425", "3008281151", "3015542154", "3013176080", "3036756245", "3004142400", "3017397663", "2134470", "9616680", "1827096", "1226544", "9613369", "2245304", "1835251", "1834331", "3043543260", "1220477", "3008544874", "1221053", "3006395932", "3026771806", "3010536692", "3012130008", "3001278222", "1020279", "1835444", "3007913880", "3006017180", "3008262872", "3004188066", "3009888740", "3011683674", "3009882462", "3011274144", "3009959868", "3009973336", "3002907620", "3008556682", "2183744", "3009475821", "3009732568", "3002807314", "3003387384", "3009998573", "1720929", "3001284227", "1018470", "3005551626", "3008668801", "3003477135", "3014302784", "3013302242", "3035366890", "1833920", "3003761012", "1047843", "1450662", "1643817", "3033509898", "3010123256", "3038503932", "3005061536", "3009813841", "3013014058", "3010173425", "3015207155", "1722511", "3002806470", "1644408", "9611390", "3025603301", "3008021110", "1526534", "3003541440", "1643264", "8044172", "3010120135", "1529009", "3010220595", "3014763043", "1038671", "3002806603", "3022142628", "3011277306", "1043653", "2249615", "3003639920", "3027484613", "9681465", "3002807310", "3021008900", "3009973505", "3011295718", "2249697", "8043792", "9614209", "1649518", "3008572101", "9610726", "3008395353", "3007740680", "1828464", "3023852420", "3012725451", "1825034", "3030412764", "1828288", "3020967480", "3036773273", "3013791180", "3007366790", "3016438694" ], "fei_number": [ "3031800723", "3016778562", "3009173317", "3002806653", "3010041693", "3009546990", "1000115656", "3002806725", "3008281151", "3015542154", "3013176080", "3036756245", "1000221916", "3017397663", "3004142400", "1827096", "2245304", "1000306340", "3043543260", "3002459190", "1220477", "3008544874", "1221053", "3006395932", "3026771806", "3002807172", "3010536692", "3012130008", "3001278222", "1020279", "3002807036", "1000116912", "3007913880", "3006017180", "3008262872", "3004188066", "3009888740", "3011683674", "3009882462", "3011274144", "3009959868", "3009973336", "3002907620", "3008556682", "2183744", "3009475821", "3009732568", "3002807314", "3003387384", "3009998573", "3000717687", "3001284227", "1018470", "1720929", "3005551626", "3008668801", "3003477135", "3014302784", "3002807113", "3013302242", "3035366890", "3003761012", "1047843", "1450662", "1643817", "3033509898", "3010123256", "3038503932", "3005061536", "3009813841", "3001049282", "3013014058", "3015207155", "3002806470", "3025603301", "3008021110", "1526534", "3003541440", "1643264", "3010120135", "3002462840", "3003128516", "3010220595", "3001236277", "3014763043", "1038671", "3002806603", "3022142628", "3011277306", "1043653", "3002807893", "1000143502", "3003639920", "3003070421", "3027484613", "3002807310", "3021008900", "3007282753", "3009973505", "3011295718", "3008572101", "3008395353", "3002808269", "3007740680", "1828464", "3023852420", "3012725451", "1825034", "3030412764", "1828288", "3020967480", "3036773273", "3002806773", "3000205591", "1000149660", "3013791180", "3016438694" ], "device_name": "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3358", "device_class": "2" } } ] }