{ "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": "160165", "product_res_number": "Z-0269-2018", "event_date_initiated": "2017-06-16", "event_date_created": "2017-12-20", "recall_status": "Terminated", "event_date_terminated": "2018-09-06", "res_event_number": "78705", "product_code": "KWI", "k_numbers": [ "K051385" ], "product_description": "ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610.\n\nThe stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.", "code_info": "Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610", "firm_fei_number": "1825034", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-6989", "additional_info_contact": "574-371-3071", "reason_for_recall": "Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.", "root_cause_description": "Packaging change control", "action": "Zimmer Biomet sent US Fiedl action notices 6/16/17 via email and fed Ex.\nOn 9/5/17, firm expanded their recall to include 1 lot and distributed Amended notices via email and FedEx", "distribution_pattern": "US, Canada, OUS.", "openfda": { "k_number": [ "K032806", "K131845", "K172688", "K132735", "K041858", "K030384", "K112030", "K062898", "K212872", "K183618", "K023604", "K002644", "K051385", "K032686", "K991915", "K030237", "K231188", "K001385", "K040611", "K060731", "K992220", "K092721", "K982288", "K213563", "K984290", "K012551", "K000658", "K192754", "K944507", "K233592", "K885146", "K011819", "K994041", "K260624" ], "registration_number": [ "1020279", "3020703621", "2134285", "2029275", "1822565", "3010041430", "3006846753", "1423662", "3009417901", "3000931034", "3015542154", "2249697", "1828464", "3009959868", "3010178296", "3010386387", "1825034", "2133928", "1835572", "1649833", "1043534", "1220246", "3011580264", "3007993775", "3008337808", "3009826895", "3008421730", "1720929", "3018094310", "9610726", "3004142400", "3006742481", "1043653", "3010120148", "1522875", "1058084", "3010667733", "2028632", "1649518", "3008868758", "3004748528", "3014302784", "3005061536", "2027487", "1450662", "3009241418", "3010120104", "3005641619", "3008812560", "3010863450", "1030489", "3006128100", "1526534", "8010379", "1226544", "3019767615", "3038503932", "3004188066", "1319429", "2183946", "1834331", "3002907620", "3011683674", "3010049501", "3008108789", "3004464325", "1424263", "3010331645", "1834379", "3002807295", "3010032903", "1226425", "3033509898", "3021008900", "3003761012", "3007366790", "1818910", "3010120135", "1824199", "3015399803", "3006356043", "2032098", "2134947", "8031020", "9611390", "3004635447", "3006783837", "3036756245", "3003477135", "3025603301", "1649379", "3010173425", "3013176080", "3034676720", "3035366890", "3043543260", "3002807310", "3015207155", "3015516266", "3025141", "1222928", "3003403260" ], "fei_number": [ "1020279", "3003128516", "1000116116", "3020703621", "1000125930", "3000717902", "3001452082", "3010041430", "3006846753", "1000120314", "3009417901", "1000199976", "3000931034", "3015542154", "1828464", "3009959868", "3010386387", "1825034", "1000120613", "3002807036", "1043534", "1000306340", "1220246", "3011580264", "3007993775", "3002807172", "3007282753", "3008337808", "3001236277", "3009826895", "3008421730", "1720929", "3018094310", "1000125025", "3004142400", "3006742481", "3003110073", "1000220733", "3001584317", "1000306431", "1043653", "3010120148", "1522875", "1000477302", "3002807830", "3010667733", "3008868758", "3004748528", "1000306303", "3014302784", "3005061536", "2027487", "1450662", "3009241418", "3003058448", "3010120104", "3005641619", "3008812560", "3010863450", "3006128100", "1526534", "3002806773", "3019767615", "3038503932", "3004188066", "3002907620", "3011683674", "3002287318", "1000221981", "3010049501", "3008108789", "3004464325", "3010938185", "3000215273", "3010331645", "3002807295", "3010032903", "3033509898", "3021008900", "3003761012", "1818910", "3010120135", "1824199", "3015399803", "3006356043", "3004635447", "3036756245", "3000718490", "3003477135", "3003015552", "3025603301", "3013176080", "3003018882", "3034676720", "3035366890", "3003070421", "3043543260", "3002807310", "3015207155", "3015516266", "3009322142", "3003403260" ], "device_name": "Prosthesis, Elbow, Hemi-, Radial, Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3170", "device_class": "2" } } ] }