{ "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": "191837", "product_res_number": "Z-0651-2022", "event_date_initiated": "2021-12-30", "event_date_created": "2022-02-17", "recall_status": "Terminated", "event_date_terminated": "2024-03-14", "res_event_number": "89520", "product_code": "JDG", "k_numbers": [ "K121308" ], "product_description": "Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044", "code_info": "GTIN: 04546540509048; Lot G7900236", "firm_fei_number": "3003070421", "recalling_firm": "Howmedica Osteonics Corp.", "address_1": "325 Corporate Dr", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2006", "additional_info_contact": "Elizabeth Beato\n845-260-1849", "reason_for_recall": "There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.", "root_cause_description": "Labeling mix-ups", "action": "An URGENT MEDICAL DEVICE RECALL dated 12/30/21 was sent to customers.\n\nActions Needed:\nOur records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this communication. We therefore request that you read this notice carefully and complete the following actions.\n1.\tPlease inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware.\n2.\tImmediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. \n3.\tDiscontinue use of the recalled Exeter V40 Cemented Hip Stems, Lots #G7900352 and #G7900236 and return the product.\n4.\tHospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-866-660-8956 or email to strykerortho6067@sedgwick.com. \n5.\tHospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions.\n6.\tBranches/Agencies Only: Please forward this Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address.\n\nAtt. Regina Short (Quality Manager) / PFA# 2847072\nStryker\nGlobal Quality & Operations\nTullagreen Building, IDA Business & Technology Park,\nCarrigtwohill, Cork, Ireland\nT45 HE42\n\n7.\tPlease contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.\n\nPlease assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. \n\nUnder 21 CFR 803, manufacturers are also req", "product_quantity": "59 devices", "distribution_pattern": "The product was distributed to the following US states: MI", "openfda": { "k_number": [ "K760651", "K874575", "K992234", "K173499", "K812669", "K874740", "K770161", "K772120", "K792329", "K812687", "K931194", "K780357", "K933871", "K761003", "K935078", "K915391", "K193546", "K962002", "K953067", "K851566", "K780497", "K911595", "K942479", "K001984", "K942028", "K874100", "K800051", "K922682", "K760976", "K761243", "K770184", "K924099", "K874617", "K770471", "K760974", "K915787", "K833468", "K770219", "K873089", "K945783", "K760106", "K761146", "K951083", "K873458", "K760108", "K760107", "K915385", "K800050", "K942027", "K770473", "K873627", "K780773", "K212431", "K780329", "K953653", "K761002", "K801006", "K955171", "K874868" ], "registration_number": [ "1020279", "3007366790", "1643264", "2245304", "3009888740", "3009756327", "3013014058", "3012392319", "9616680", "2249615", "9610726", "3016438694", "3006395932", "3010170586", "3038503932", "3004142400", "3005562917", "1221053", "9613369", "3011295718", "1043653", "1834331", "3030412764", "3011683674", "3009973505", "3013302242", "3036756245", "1644408", "1721676", "9614209", "3008556682", "3025603301", "3015542154", "3014315669", "2249697", "8010935", "1649518", "3010173425", "1828464", "3013176080", "1825034", "3004371426", "3004638532", "3035366890", "3009882462", "3014302784", "1220477", "3005061536", "3002807314", "1000550978", "1450662", "3009241418", "3009732568", "3007923096", "3006017180", "3002807310", "3015207155", "3033509898", "3009973336", "3021008900" ], "fei_number": [ "3002807172", "1020279", "1643264", "1000116912", "3007282753", "2245304", "3009888740", "3002807893", "3013014058", "3012392319", "3001236277", "3006395932", "3016438694", "3010170586", "3038503932", "3004142400", "3005562917", "1221053", "3011295718", "1043653", "3030412764", "3003386935", "3011683674", "3009973505", "3013302242", "3036756245", "1721676", "3008556682", "3002807646", "3025603301", "3015542154", "3014315669", "1828464", "3013176080", "1825034", "3004638532", "3035366890", "3002807038", "3009882462", "3014302784", "1220477", "3005061536", "3002806725", "3003070421", "3002807314", "1000550978", "1450662", "3009241418", "3009732568", "3002807036", "3007923096", "3002459190", "3006017180", "3001049282", "3002807310", "3015207155", "1000306340", "3033509898", "3009973336", "3021008900" ], "device_name": "Prosthesis, Hip, Femoral Component, Cemented, Metal", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3360", "device_class": "2" } } ] }