{ "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": "142027", "product_res_number": "Z-0584-2016", "event_date_initiated": "2015-11-16", "event_date_created": "2016-01-05", "recall_status": "Terminated", "event_date_terminated": "2016-08-25", "res_event_number": "72719", "product_code": "KWL", "k_numbers": [ "K061243" ], "product_description": "BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: \n74121238, MODULAR HEAD 38 MM -8MM\n74121242, MODULAR HEAD 42 MM -8MM\n74121246, MODULAR HEAD 46 MM -8MM\n74121250, MODULAR HEAD 50 MM -8MM\n74121254, MODULAR HEAD 54 MM -8MM\n74121258, MODULAR HEAD 58 MM -8MM\n74121338, MODULAR HEAD 3 8MM -4 (SHORT)\n74121342, MODULAR HEAD 42 MM -4 (SHORT)\n74121346, MODULAR HEAD 46 MM -4 (SHORT)\n74121350, MODULAR HEAD 50 MM -4 (SHORT)\n74121354, MODULAR HEAD 54 MM -4 (SHORT)\n74121358, MODULAR HEAD 58 MM -4 (SHORT)\n74121438, MODULAR HEAD 38 MM +0 (MED)\n74121442, MODULAR HEAD 42 MM +0 (MED)\n74121446, MODULAR HEAD 46 MM +0 (MED)\n74121450, MODULAR HEAD 50 MM +0 (MED)\n74121454, MODULAR HEAD 54 MM +0 (MED)\n74121458, MODULAR HEAD 58 MM +0 (MED)\n74121538, MODULAR HEAD 38 MM +4 (LONG)\n74121542, MODULAR HEAD 42 MM +4 (LONG)\n74121546, MODULAR HEAD 46 MM +4 (LONG)\n74121550, MODULAR HEAD 50 MM +4 (LONG)\n74121554, MODULAR HEAD 54 MM +4 (LONG)\n74121558, MODULAR HEAD 58 MM +4 (LONG)", "code_info": "All codes", "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": "Joe Metzger\n978-749-1330", "reason_for_recall": "The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.", "root_cause_description": "Labeling design", "action": "The firm sent their field safety notices on 11/16/2015 by letter delivered by Fed Ex (overnight) and email. Non- responding consignees will be contacted within 4 weeks of the initial notice", "product_quantity": "16 units in US", "distribution_pattern": "Worldwide distribution. US nationwide, France, UAE, Austria, Australia, Belgium, CANADA, Switzerland, Germany, Denmark, Spain, Finland, UK, Hong Kong, ISRAEL, India, Italy, Japan, South Korea, Netherlands, Norway, Poland, PORTUGAL, Sweden, SINGAPORE, Thailand, Turkey, and SOUTH AFRICA.", "openfda": { "k_number": [ "K062408", "K062273", "K904119", "K905349", "K920231", "K924379", "K896105", "K965198", "K831420", "K800207", "K903877", "K173967", "K973614", "K855228", "K820755", "K821343", "K260536", "K014226", "K954077", "K101356", "K974807", "K984028", "K872535", "K990309", "K842465", "K924050", "K042973", "K844486", "K063791", "K981451", "K922146", "K926120", "K960538", "K950563", "K903884", "K872025", "K833599", "K803191", "K822321", "K252326", "K951355", "K903885", "K031841", "K844818", "K030972", "K262290", "K842234", "K842559", "K852584", "K943778", "K940190", "K811416", "K143184", "K903240", "K191981", "K872776", "K811738", "K864085", "K965156", "K905334", "K884889", "K192995", "K792181", "K844487", 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"1000086912", "3002807893", "1000139987", "3010057495", "3012275107", "3006356043", "1643817", "3006849754", "1221053", "3010536692", "3004153896", "3014252644", "3004635447", "2246552", "3010898856", "3007740680", "3008110533", "3036756245", "3003015552", "3025603301", "3000196378", "3002807113", "3013176080", "3016438761", "3034676720", "3035366890", "3003070421", "3002806725", "3014763043", "3001278222", "3002459190", "3006017180", "3003916006", "3002807310", "3015207155", "3015516266", "3006085220" ], "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3360", "device_class": "2" } } ] }