{ "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-1163-2016", "product_description": "Product 65 consists of all product under product code: KTT and same usage: Item no:\t 119413594\tVERSA-FX II KEYLESS SHORT 119413595\tVERSA-FX II KEYLESS SHORT 119413596\tVERSA-FX II KEYLESS SHORT 119413004\tVERSA-FX II KEYLESS TUBE 119413005\tVERSA-FX II KEYLESS TUBE 119413006\tVERSA-FX II KEYLESS TUBE 119413008\tVERSA-FX II KEYLESS TUBE 119413504\tVERSA-FX II KEYLESS TUBE 119413505\tVERSA-FX II KEYLESS TUBE 119413506\tVERSA-FX II KEYLESS TUBE 119413508\tVERSA-FX II KEYLESS TUBE 119414004\tVERSA-FX II KEYLESS TUBE 119414005\tVERSA-FX II KEYLESS TUBE 119414006\tVERSA-FX II KEYLESS TUBE 119414008\tVERSA-FX II KEYLESS TUBE 119414504\tVERSA-FX II KEYLESS TUBE 119414506\tVERSA-FX II KEYLESS TUBE 119414508\tVERSA-FX II KEYLESS TUBE 119415004\tVERSA-FX II KEYLESS TUBE 119415005\tVERSA-FX II KEYLESS TUBE 119415006\tVERSA-FX II KEYLESS TUBE 119415008\tVERSA-FX II KEYLESS TUBE 119313094\tVERSA-FX II SHORT TUBE PL 119313095\tVERSA-FX II SHORT TUBE PL 119313096\tVERSA-FX II SHORT TUBE PL 119313594\tVERSA-FX II SHORT TUBE PL 119313595\tVERSA-FX II SHORT TUBE PL 119313596\tVERSA-FX II SHORT TUBE PL 119314094\tVERSA-FX II SHORT TUBE PL 119314594\tVERSA-FX II SHORT TUBE PL 119314595\tVERSA-FX II SHORT TUBE PL 119315094\tVERSA-FX II SHORT TUBE PL 119315095\tVERSA-FX II SHORT TUBE PL 119313002\tVERSA-FX II STD TUBE PLAT 119313003\tVERSA-FX II STD TUBE PLAT 119313004\tVERSA-FX II STD TUBE PLAT 119313005\tVERSA-FX II STD TUBE PLAT 119313006\tVERSA-FX II STD TUBE PLAT 119313008\tVERSA-FX II STD TUBE PLAT 119313010\tVERSA-FX II STD TUBE PLAT 119313012\tVERSA-FX II STD TUBE PLAT 119313502\tVERSA-FX II STD TUBE PLAT 119313503\tVERSA-FX II STD TUBE PLAT 119313504\tVERSA-FX II STD TUBE PLAT 119313505\tVERSA-FX II STD TUBE PLAT 119313506\tVERSA-FX II STD TUBE PLAT 119313508\tVERSA-FX II STD TUBE PLAT 119313510\tVERSA-FX II STD TUBE PLAT 119313512\tVERSA-FX II STD TUBE PLAT 119314002\tVERSA-FX II STD TUBE PLAT 119314003\tVERSA-FX II STD TUBE PLAT 119314004\tVERSA-FX II STD TUBE PLAT 119314005\tVERSA-FX II STD TUBE PLAT 119314006\tVERSA-FX II STD TUBE PLAT 119314502\tVERSA-FX II STD TUBE PLAT 119314503\tVERSA-FX II STD TUBE PLAT 119314504\tVERSA-FX II STD TUBE PLAT 119314505\tVERSA-FX II STD TUBE PLAT 119314506\tVERSA-FX II STD TUBE PLAT 119314510\tVERSA-FX II STD TUBE PLAT 119314512\tVERSA-FX II STD TUBE PLAT 119315003\tVERSA-FX II STD TUBE PLAT 119315004\tVERSA-FX II STD TUBE PLAT 119315005\tVERSA-FX II STD TUBE PLAT 119315006\tVERSA-FX II STD TUBE PLAT 119315012\tVERSA-FX II STD TUBE PLAT 119315014\tVERSA-FX II STD TUBE PLAT 119315018\tVERSA-FX II STD TUBE PLAT 119309008\tVERSA-FX II SUPRACONDYLR 119309010\tVERSA-FX II SUPRACONDYLR 119309012\tVERSA-FX II SUPRACONDYLR 119309014\tVERSA-FX II SUPRACONDYLR 119309506\tVERSA-FX II SUPRACONDYLR 119309508\tVERSA-FX II SUPRACONDYLR 119309510\tVERSA-FX II SUPRACONDYLR 119309512\tVERSA-FX II SUPRACONDYLR 119309514\tVERSA-FX II SUPRACONDYLR 119309516\tVERSA-FX II SUPRACONDYLR 119309522\tVERSA-FX II SUPRACONDYLR 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": "5538", "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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