{ "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-1121-2016", "product_description": "Product 23 consists of all product code: JDI and same usage: Item no:\t 801100220\tCPT 2 HIP STEM, X-OFFSET 801100320\tCPT 3 HIP STEM, X-OFFSET 801100420\tCPT 4 HIP STEM, X-OFFSET 801100005\tCPT HIP STEM PETITE 801100700\tCPT HIP STEM SZ 2 LONG 801100800\tCPT HIP STEM SZ 3 LONG 801100222\tCPT MOD HD ST/ST 22MED SH 801100322\tCPT MOD HD ST/ST 22MMD LN 801100122\tCPT MOD HD ST/ST 22MMD SH 801100126\tCPT MOD HD ST/ST 26MMD SH 801100328\tCPT MOD HD ST/ST 28MMD LN 801100228\tCPT MOD HD ST/ST 28MMD ME 801100128\tCPT MOD HD ST/ST 28MMD SH 801100332\tCPT MOD HD ST/ST 32MMD LN 801100232\tCPT MOD HD ST/ST 32MMD ME 801100132\tCPT MOD HD ST/ST 32MMD SH 801100100\tCPT MODULAR STEM SIZE 1 S 801100200\tCPT MODULAR STEM SIZE 2 S 801100300\tCPT MODULAR STEM SIZE 3 S 801100400\tCPT MODULAR STEM SIZE 4 S 801100500\tCPT MODULAR STEM SIZE 5 S For use in total or hemi hip arthroplasty", "product_quantity": "10", "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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