Recall Z-2926-2020 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Exactech, Inc.
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
| Date | Aug 10, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 11 units |
| Distribution | Domestic: CO,FL,OK, PA. International: Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152217 | Exactech Vantage Total Ankle System Exactech, Inc., Mar 10, 2016 |