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Zimmer Biomet, Inc. recalls various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder Sy
Recalled April 26, 2017 · FDA recall Z-1859-2017 · Zimmer Biomet
Hazard
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. · FDA Class II
Units
28,253 in total
Sold at
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
Description
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Product
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →