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Exactech, Inc. recalls The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Recalled September 9, 2020 · FDA recall Z-2926-2020 · Exactech
Hazard
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. · FDA Class II
Units
11 units
Sold at
Domestic: CO,FL,OK, PA. International: Chile
Description
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.
Product
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →