FDAFDA · Food and drugs·Recall number Z-1863-2017
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Published April 26, 2017 · Recall initiated: February 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- 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
- Lot
- Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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