CoreLink LLC: Medical Device Recall in 2023 - (Recall #: Z-0954-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 20, 2022

Date Posted: January 18, 2023

Recall Number: Z-0954-2023

Event ID: 91109

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.

Status: Terminated

Product Quantity: 18 units

Code Information:

UDI/DI M725AT32080, Lot Codes: SM135217, SM129260

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated