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Biomet, Inc. recalls Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Recalled June 24, 2015 · FDA recall Z-1798-2015 · Biomet
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. · FDA Class II
Units
27
Sold at
Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
Description
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.
Product
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →