{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Mercedita", "state": "PR", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "72900", "recalling_firm": "Zimmer Manufacturing B.V.", "address_1": "Turpeaux Industrial Park Rd 1 km 123.4", "address_2": "", "postal_code": "00715", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-1114-2016", "product_description": "Product 16 consists of all product under poduct code: KWY and same usage: Item no:\t 500103822\tBIPOLAR LINER 38MM OD X 2 500103922\tBIPOLAR LINER 39MM OD X 2 500104022\tBIPOLAR LINER 40/41MM OD 500104026\tBIPOLAR LINER 40MM OD X 2 500104222\tBIPOLAR LINER 42/43 OD X 500104226\tBIPOLAR LINER 42MM OD X 2 500104428\tBIPOLAR LINER 44/45/46MM 500104422\tBIPOLAR LINER 44MM OD X 2 500104426\tBIPOLAR LINER 44MM OD X 2 500104728\tBIPOLAR LINER 47/48/49MM 500104722\tBIPOLAR LINER 47MM OD X 2 500104726\tBIPOLAR LINER 47MM OD X 2 500104732\tBIPOLAR LINER 47MM OD X 3 500105028\tBIPOLAR LINER 50/51/52MM 500105022\tBIPOLAR LINER 50MM OD X 2 500105026\tBIPOLAR LINER 50MM OD X 2 500105328\tBIPOLAR LINER 53/54/55MM 500105322\tBIPOLAR LINER 53MM OD X 2 500105326\tBIPOLAR LINER 53MM OD X 2 500105728\tBIPOLAR LINER 57/58MM OD 500105722\tBIPOLAR LINER 57MM OD X 2 500106028\tBIPOLAR LINER 60/62MM OD 500106828\tBIPOLAR LINER 68/70MM OD 500106832\tBIPOLAR LINER 68MM OD X 3 500107228\tBIPOLAR LINER 72MM OD X 2 500103800\tBIPOLAR SHELL 38MM OD 500103900\tBIPOLAR SHELL 39MM OD 500104000\tBIPOLAR SHELL 40MM OD 500104100\tBIPOLAR SHELL 41MM OD 500104200\tBIPOLAR SHELL 42MM OD 500104300\tBIPOLAR SHELL 43MM OD 500104400\tBIPOLAR SHELL 44MM OD 500104500\tBIPOLAR SHELL 45MM OD 500104600\tBIPOLAR SHELL 46MM OD 500104700\tBIPOLAR SHELL 47MM OD 500104800\tBIPOLAR SHELL 48MM OD 500104900\tBIPOLAR SHELL 49MM OD 500105000\tBIPOLAR SHELL 50MM OD 500105100\tBIPOLAR SHELL 51MM OD 500105200\tBIPOLAR SHELL 52MM OD 500105300\tBIPOLAR SHELL 53MM OD 500105400\tBIPOLAR SHELL 54MM OD 500105500\tBIPOLAR SHELL 55MM OD 500105700\tBIPOLAR SHELL 57MM OD 500105800\tBIPOLAR SHELL 58MM OD 500106000\tBIPOLAR SHELL 60MM OD 500106200\tBIPOLAR SHELL 62MM OD 500107000\tBIPOLAR SHELL 70MM OD Product Usage: For use in total or hemi hip arthroplasty", "product_quantity": "8773", "reason_for_recall": "As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. 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