Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Reported: June 24, 2015 Initiated: April 22, 2015 #Z-1798-2015
Product Description
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Reason for Recall
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 27
- Distribution
- Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.. Recalled by Biomet, Inc.. Units affected: 27.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1798-2015.
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