Recall Z-0361-2020 ยท NDL Pin, Fixation, Smooth, Metallic
Exactech, Inc.
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
| Date | Oct 2, 2019 |
| Status | Terminated |
| Reason | Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended. |
| Root cause | Error in labeling |
| Action | Exactech notified customers on about 10/02/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that the 2.4mm x 2.5" Fluted Pin Pouch was found to contain a single pin rather than four (4) as labeled. Instructions included to immediately cease distribution or use of the affected product, provide the information to customers if further distributed, identify and quarantine any of the affected devices in inventory, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email to recalls@exac.com. |
| Quantity | 9 units |
| Distribution | US Nationwide distribution in the states of GA, NY, OH, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.