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Zimmer Biomet, Inc. recalls various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional spe
Recalled April 26, 2017 · FDA recall Z-1858-2017 · 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 BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →