The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
This recall is currently active, issued August 10, 2020. It was issued by Exactech, Inc..
- Company
- Exactech, Inc.
- Recall Initiated
- August 10, 2020
- Recall Number
- Z-2926-2020
- Quantity
- 11 units
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
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
Domestic: CO,FL,OK, PA. International: Chile
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.
Root Cause
Error in labeling
Action Taken
On August 18, 2020 Exactech sent an Urgent Product Recall Notice to all its consignees with the following instructions: -Immediately cease distribution or use of this product. -Extend this information to your accounts that may have this product in their possession. - Identify and quarantine any of the subject devices in your inventory (including loaner kits). -Complete and returned the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com.