{ "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": "Warsaw", "state": "IN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "76507", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "56 E Bell Dr", "address_2": "N/A", "postal_code": "46582-6989", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK", "recall_number": "Z-1861-2017", "product_description": "various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.", "product_quantity": "28,253 in total", "reason_for_recall": "Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.", "recall_initiation_date": "20170217", "center_classification_date": "20170418", "termination_date": "20180129", "report_date": "20170426", "code_info": "Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 466430 516220 516230 516240 584590 609910 Item 141265 466440 527490 609920 684740 Item 141266 584620 Item 141268 527590 Item 141481 412820 920390 Item 141482 289810 412870 805950 920410 Item 141483 537790 Item 141484 412920 903910 Item 141485 920420 Item 141512 781920 781960 805970 Item 141514 806010 Item 141515 827960 Item 150410 241990 373830 596750 Item 150411 231200 373840 373850 Item 150412 129940 231210 231220 596910 Item 150413 129950 Item 150414 409730 Item150415 129960 596920 Item 150476 510910 510930 510940 Item 150477 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