FDA-Device2017-04-26Class II
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Zimmer Biomet, Inc.
Hazard
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Sold states
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
Affected count
28,253 in total
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1863-2017Don't want to check this manually?
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