Vanguard M Unicondylar Tibial Trial For use during knee recall
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Why was Vanguard M Unicondylar Tibial Trial For use during knee 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270
- Product
- Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
- Recalling firm
- Biomet, Inc.
- Quantity
- 27
- Distribution
- Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
- Recall date
- June 24, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)