{ "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-1125-2016", "product_description": "Product 27 consists of all product under product code: HSB and same usage: Item no:\t 234703104\tDISTAL MEDIAL FEMORAL CON 234703206\tDISTAL MEDIAL FEMORAL CON 234703208\tDISTAL MEDIAL FEMORAL CON 234800504\tDISTAL POSTERIOR/LATERAL 234800506\tDISTAL POSTERIOR/LATERAL 234800508\tDISTAL POSTERIOR/LATERAL 234800510\tDISTAL POSTERIOR/LATERAL 234800604\tDISTAL POSTERIOR/LATERAL 234800606\tDISTAL POSTERIOR/LATERAL 234800608\tDISTAL POSTERIOR/LATERAL 234800610\tDISTAL POSTERIOR/LATERAL 234800614\tDISTAL POSTERIOR/LATERAL Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.", "product_quantity": "945", "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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