Z-0954-2023 Class II Terminated
FDA device recall Z-0954-2023 was initiated by CoreLink LLC on October 20, 2022 and is designated Class II. Reason for recall: Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy. The recall status is terminated (terminated August 20, 2024). Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2023
- Initiation Date
- October 20, 2022
- Termination Date
- August 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Reason for Recall
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI M725AT32080, Lot Codes: SM135217, SM129260