Z-0361-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 2, 2019
- Termination Date
- May 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
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.
Reason for Recall
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Distribution Pattern
US Nationwide distribution in the states of GA, NY, OH, VA.
Code Information
Catalog Number: 351-90-22; UDI Number: 10885862567529; Expiration Date: 08/28/2028; Serial Numbers (6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, 6189273); Packaging Lots Numbers (49079322, 49079321); Manufacturing Lot Number:19030412