Z-2365-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- May 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Reason for Recall
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Distribution Pattern
Worldwide distribution.
Code Information
Lot Numbers: 1616800188 1719300113 1828900138 2023300147 1703200130 1816400079 1833800127 2026000048 1713700156 1822000123 2009300120