Device product
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Z-0954-2023
Product summary
- Firm
- CoreLink LLC
- Event
- Event 91109
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-0954-2023
Official wording
Reason: Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Code information: UDI/DI M725AT32080, Lot Codes: SM135217, SM129260
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.