Reported Jun 24, 2015 · Terminated

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

Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Lot codes and dates

14 of 14 products

Products covered by this recall
Model / numberProduct as published
32-423102Lot 414930
32-423106Lot 116490
32-423107Lot 785220
32-423108Lot 873780
32-423109Lot 070420 and 785250
32-423115Lot 670630
32-423119Lot 672920
32-423116Lot 785290
32-423101Lot 073640
32-423102Lot 785170
32-423109Lot 785180
32-423124Lot 785260
32-423110Lot 024760
Lot 785270
Amount recalled
27

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Biomet, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 22, 2016 · Data as of Sep 19, 4:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.