Biomet, Inc. recalls Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

Recall date

April 22, 2015

Source

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

Recall number

Z-1798-2015

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.

Why it was recalled

The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.