medical Class II Updated 2020-09-09

Exactech, Inc. recalls The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4

Recalled Product

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.


Hazard / Issue

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.

Issued by

FDA

Affected States: CO, FL, OK, PA
Lot/Code Info: Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.
View official government recall

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