Biomet product recalled over sterility concerns

Recall date

April 1, 2016

Source

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

Official notice title

Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.

Recall number

Z-1822-2016

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

Why it was recalled

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

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 trauma and sports medicine instruments and implants. Pin, fixation, smooth.