Device evidence

device-recall:cfres:177052

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.

Official recall number

Z-0361-2020

Evidence summary

Product code: NDL
Recall status: Terminated
Event initiated: October 02, 2019
Root cause: Error in labeling
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0361-2020