FDA-Device2015-06-24Class II
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Biomet, Inc.
Hazard
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.
Sold states
Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
Affected count
27
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2015Don't want to check this manually?
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