Reported Sep 9, 2020 · Ongoing
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Exactech, 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: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
- Lot codes and dates
- Catalog Number350-22-44
- Lot numbers05144883
- and 05144884 Serial Numbers
64179846417989641799664179976417998641800264180036488668648867364886746488675
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
This product could cause temporary or reversible health problems — stop using it.
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