Device product
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Z-2926-2020
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 86261
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-2926-2020
Official wording
Reason: 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.
Code information: Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.
Distribution pattern: Domestic: CO,FL,OK, PA. International: Chile
Derived failure modes
-
Labeling or packaging
labeling error