Zimmer Biomet, Inc. recalls various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
- Recall date
- February 17, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1863-2017
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- 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
Why it was recalled
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
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