FDA-Device2017-04-26Class II
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.
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1858-2017Don't want to check this manually?
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