Device product

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

Z-0954-2023

October 20, 2022

Class II

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
reason.no_named_rule · v1.0.0

Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.