Z-2926-2020 Class II Ongoing
FDA device recall Z-2926-2020 was initiated by Exactech, Inc. on August 10, 2020 and is designated Class II. Reason for recall: 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, Righ… The recall status is ongoing. Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2020
- Initiation Date
- August 10, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Reason for Recall
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.
Distribution Pattern
Domestic: CO,FL,OK, PA. International: Chile
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.