FDA recall Z-0954-2023

Product

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

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2022-10-20

Report date

2023-01-18

Termination date

2024-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fenton, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0954-2023