Recall Z-0200-2018 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
| Date | May 16, 2017 |
| Status | Terminated |
| Reason | Possible inner labeling and packaged device not matching the outer label on the box. |
| Root cause | Under Investigation by firm |
| Action | Customers were notified via letter dated May 16, 2017. Instructions included to immediately cease distribution of the affected products, identify and quarantine any devices in inventory, complete and return the Recall Inventory Response Form, notify customers if further distributed. For further questions, please call (352) 377-1140. |
| Quantity | 9 |
| Distribution | Distributed in North Carolina |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152217 | Exactech Vantage Total Ankle System Exactech, Inc., Mar 10, 2016 |