{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193009", "product_res_number": "Z-1072-2022", "event_date_initiated": "2022-04-07", "event_date_created": "2022-05-12", "recall_status": "Open, Classified", "res_event_number": "89972", "product_code": "KWI", "k_numbers": [ "K183618" ], "product_description": "Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.", "code_info": "All serial numbers.\nMaterial GTIN Product\n03.405.000S\t10886982300829\tRadial Head Replacement Instr Kit;\n09.405.250S\t10886982300614\tRad Head w/Head 22 shaft 5.5 HH10 +0;\n09.405.253S\t10886982300621\tRad Head w/Head 22 shaft 5.5 HH10 +3;\n09.405.256S\t10886982300638\tRad Head w/Head 22 shaft 5.5 HH10 +6;\n09.405.260S\t10886982300645\tRad Head w/Head 22 shaft 6.5 HH10 +0;\n09.405.263S\t10886982300652\tRad Head w/Head 22 shaft 6.5 HH10 +3;\n09.405.266S\t10886982300669\tRad Head w/Head 22 shaft 6.5 HH10 +6;\n09.405.270S\t10886982300676\tRad Head w/Head 22 shaft 7.5 HH10 +0;\n09.405.273S\t10886982300683\tRad Head w/Head 22 shaft 7.5 HH10 +3;\n09.405.276S\t10886982300690\tRad Head w/Head 22 shaft 7.5 HH10 +6;\n09.405.280S\t10886982300706\tRad Head w/Head 22 shaft 8.5 HH10 +0;\n09.405.283S\t10886982300713\tRad Head w/Head 22 shaft 8.5 HH10 +3;\n09.405.286S\t10886982300720\tRad Head w/Head 22 shaft 8.5 HH10 +6;\n09.405.560S\t10886982300737\tRad Head w/Head 25 shaft 6.5 HH11 +0;\n09.405.563S\t10886982300744\tRad Head w/Head 25 shaft 6.5 HH11 +3;\n09.405.566S\t10886982300751\tRad Head w/Head 25 shaft 6.5 HH11 +6;\n09.405.570S\t10886982300768\tRad Head w/Head 25 shaft 7.5 HH11 +0;\n09.405.573S\t10886982300775\tRad Head w/Head 25 shaft 7.5 HH11 +3;\n09.405.576S\t10886982300782\tRad Head w/Head 25 shaft 7.5 HH11 +6;\n09.405.580S\t10886982300799\tRad Head w/Head 25 shaft 8.5 HH11 +0;\n09.405.583S\t10886982300805\tRad Head w/Head 25 shaft 8.5 HH11 +3;\n09.405.586S\t10886982300812\tRad Head w/Head 25 shaft 8.5 HH11 +6;\n09.405.950S\t10886982300522\tRad Head w/Head 19 shaft 5.5 HH9 +0;\n09.405.953S\t10886982300539\tRad Head w/Head 19 shaft 5.5 HH9 +3;\n09.405.956S\t10886982300546\tRad Head w/Head 19 shaft 5.5 HH9 +6;\n09.405.960S\t10886982300553\tRad Head w/Head 19 shaft 6.5 HH9 +0;\n09.405.963S\t10886982300560\tRad Head w/Head 19 shaft 6.5 HH9 +3;\n09.405.966S\t10886982300577\tRad Head w/Head 19 shaft 6.5 HH9 +6;\n09.405.970S\t10886982300584\tRad Head w/Head 19 shaft 7.5 HH9 +0;\n09.405.973S\t10886982300591\tRad Head w/Head 19 shaft 7.5 HH9 +3;\n09.405.976S\t10886982300607\tRad Head w/Head 19 shaft 7.5 HH9 +6.", "firm_fei_number": "3008812560", "recalling_firm": "Synthes (USA) Products LLC", "address_1": "1301 Goshen Pkwy", "city": "West Chester", "state": "PA", "postal_code": "19380-5986", "reason_for_recall": "DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.", "root_cause_description": "Labeling Change Control", "action": "DePuy Synthesis issued Urgent: MEDICAL DEVICE CORRECTION (Notification) on 4/14/22. Letter states reason for recall, health risk and action to take:\n\n\"\tDownload and review the updated version of the e-IFU from the following website: https://www.e-ifu.com/search-document-metadata/radial%20head%20replacement%20system \nForward this notice to all attending surgeons in your facility using this device.\n\"\t\nPlease complete, sign, and return the Business Reply Form within three (3) business days email to OneMD-Field-Actions@its.jnj.com (Please reference FA 2097468 in the subject line).\n\nNote: Product is NOT being removed from the field and does not need to be returned.", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K260624", "K231188", "K023604", "K994041", "K192754", "K002644", "K131845", "K982288", "K885146", "K233592", "K012551", "K051385", "K212872", "K992220", "K183618", "K032686", "K060731", "K944507", "K132735", "K172688", "K984290", "K030384", "K092721", "K000658", "K041858", "K991915", "K011819", "K213563", "K112030", "K062898", "K001385", "K030237", "K040611", "K032806" ], "registration_number": [ "2027487", "3004635447", "1824199", "1226544", "1220246", "3034676720", "3004188066", "3020703621", "3010667733", "1834331", "3010178296", "3008108789", "3003761012", "3006783837", "3006846753", "8010379", "3019767615", "3003477135", "3014302784", "3025603301", "1526534", "1043534", "1649518", "2134947", "1835572", "3004464325", "3010032903", "3038503932", "2249697", "3010120148", "3010386387", "3018094310", "8031020", "1226425", "2134285", "3009417901", "2028632", "3008421730", "3015516266", "3043543260", "2133928", "3035366890", "1649833", "3008337808", "2183946", "3011683674", "1649379", "1424263", "3009959868", "1720929", "3015399803", "3006742481", "3009826895", "1834379", "3004142400", "3015542154", "1423662", "3004748528", "2029275", "3013176080", "3002807295", "1020279", "1222928", "3011580264", "3007993775", "3006128100", "3007366790", "3033509898", "1828464", "1058084", "3015978338", "1030489", "3008812560", "3010120104", "2032098", "9610726", "1043653", "3010863450", "3005641619", "3036756245", "9611390", "3010049501", "1825034", "3021008900", "3000931034", "1818910", "3010331645", "3002907620", "1319429", "3005061536", "3010120135", "3010173425", "3010041430", "3008868758", "1450662", "3025141", "3015207155", "1522875", "3009241418", "3002807310", "1822565", "3006356043", "3003403260" ], "fei_number": [ "2027487", "3004635447", "1824199", "1000477302", "1220246", "3034676720", "3004188066", "3020703621", "3010667733", "1000199976", "3002287318", "3003058448", "3008108789", "3003761012", "1000221981", "3006846753", "3019767615", "3003477135", "3014302784", "3025603301", "1526534", "3009322142", "1043534", "1000120314", "3000215273", "3003128516", "3001236277", "1000120613", "1000125930", "3004464325", "3010032903", "3038503932", "3010120148", "3010386387", "3018094310", "3009417901", "3008421730", "3015516266", "3043543260", "3035366890", "3008337808", "3011683674", "3002807830", "3000717902", "3009959868", "1720929", "3015399803", "3006742481", "3009826895", "3004142400", "3015542154", "3004748528", "3013176080", "3002807295", "1020279", "3011580264", "3007993775", "3006128100", "3033509898", "1828464", "3015978338", "1000125025", "3008812560", "3010120104", "3003018882", "1000306340", "3002807036", "1000306431", "3001452082", "1043653", "1000116116", "3010863450", "3005641619", "3036756245", "3010049501", "1825034", "3021008900", "3007282753", "3000931034", "1818910", "3010331645", "3000718490", "3002807172", "3010938185", "3002907620", "3002806773", "3003070421", "3005061536", "3010120135", "1000306303", "3003015552", "3010041430", "3001584317", "3008868758", "1450662", "3015207155", "1000220733", "1522875", "3003110073", "3009241418", "3002807310", "3006356043", "3003403260" ], "device_name": "Prosthesis, Elbow, Hemi-, Radial, Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3170", "device_class": "2" } } ] }