Recall Z-1192-2017 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Integra LifeSciences Corp.
Integra Cadence Total Ankle System
| Date | Feb 11, 2017 (initiated Jan 20, 2017) |
| Status | Terminated |
| Reason | Posterior tibial fractures have been reported. |
| Root cause | Use error |
| Action | The firm intends to update the surgical technique only. No product will be returned. US and non-US consignees were notified by letter delivered by traceable fax or e-mail on 01/20/2017. |
| Quantity | 944 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151459 | Integra Total Ankle Replacement System Ascension Orthopedics, Aug 31, 2015 |