Zimmer Biomet, Inc. recalls various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality c…

Recall date

February 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1858-2017

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 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.