{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104199", "product_res_number": "Z-0075-2012", "event_date_initiated": "2011-07-14", "event_date_posted": "2011-10-20", "recall_status": "Terminated", "event_date_terminated": "2013-11-15", "res_event_number": "59968", "product_code": "MEH", "k_numbers": [ "K994366" ], "product_description": "Total Hip Joint Replacement\n\nAccolade TMZF Plus 127 Neck Angle V40 Hip Stem #3\n\nAccolade TMZF Plus 127 Neck Angle V40 Hip Stem #5\n\nHowmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 \nA subsidiary of Stryker Corp.\n\nStryker France\nZAC Satolos Green Pusignan\nAv de Staolas Green 69881 Metziae\nCedex France\n\nThe TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper.", "code_info": "K994366 6021-0335 6021-0537  Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3; Catalog #6021-0335 Lot Code 35427003;  Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5; Catalog #6021-0537 Lot Code 35202601", "firm_fei_number": "3003070421", "recalling_firm": "Stryker Howmedica Osteonics Corp.", "address_1": "325 Corporate Drive", "city": "Mahwah", "state": "NJ", "postal_code": "07430", "additional_info_contact": "Ms. Colleen O' Meara\n201-972-2100", "reason_for_recall": "Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem.", "root_cause_description": "Mixed-up of materials/components", "action": "Stryker Orthopaedics sent an \"URGENT: PRODUCT RECALL\" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice.", "product_quantity": "21 units", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K241472", "K032300", "K200045", "K926299", "K961388", "K990203", "K083116", "K231873", "K023302", "K955305", "K100481", "K963959", "K020615", "K942891", "K082892", "K243839", "K911585", "K242315", "K210581", "K896047", "K060437", "K113039", "K040680", "K221104", "K971422", "K150855", "K160907", "K231178", "K925607", "K910156", "K980070", "K935453", "K912263", "K954023", "K915655", "K211742", "K153772", "K220495", "K043079", "K912713", "K912922", "K153649", "K983870", "K941366", "K251052", "K162303", "K994366", "K951932", "K932017", "K000242", "K982032", "K122853", "K072020", "K915617", "K021108", "K113320", "K090982", "K001448", "K021403", "K912395", "K020572", "K081124", "K951671", "K162732", "K052426", "K181778", "K020963", "K961732", "K153131", "K922613", 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