{ "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-1119-2016", "product_description": "Product 21 consists of all product under product code: JDI and same usage: Item no:\t 811400218\tCPT 12/14 COCR REVISION S 811400318\tCPT 12/14 COCR REVISION S 811400420\tCPT 12/14 COCR REVISION S 811400423\tCPT 12/14 COCR REVISION S 811400426\tCPT 12/14 COCR REVISION S 811400010\tCPT 12/14 COCR SIZE 0 EXT 811400000\tCPT 12/14 COCR SIZE 0 STD 811400110\tCPT 12/14 COCR SIZE 1 EXT 811400100\tCPT 12/14 COCR SIZE 1 STD 811400210\tCPT 12/14 COCR SIZE 2 EXT 811400200\tCPT 12/14 COCR SIZE 2 STD 811400230\tCPT 12/14 COCR SIZE 2 XEX 811400310\tCPT 12/14 COCR SIZE 3 EXT 811400300\tCPT 12/14 COCR SIZE 3 STD 811400330\tCPT 12/14 COCR SIZE 3 XEX 811400410\tCPT 12/14 COCR SIZE 4 EXT 811400400\tCPT 12/14 COCR SIZE 4 STD 811400430\tCPT 12/14 COCR SIZE 4 XEX 811400510\tCPT 12/14 COCR SIZE 5 EXT 811400500\tCPT 12/14 COCR SIZE 5 STD 811400530\tCPT 12/14 COCR SIZE 5 XEX Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.", "product_quantity": "1209", "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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