PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 26, 2017 Initiated: February 17, 2017 #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.

Reason for Recall

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
28,253 in total
Distribution
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
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 28,253 in total.
Why was this product recalled? ▼
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1861-2017.

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