FDA-Device2020-09-09Class II
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Exactech, Inc.
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.
Sold states
Domestic: CO,FL,OK, PA. International: Chile
Affected count
11 units
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2926-2020Don't want to check this manually?
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