Recall Z-0954-2023— CoreLink LLC

Name: FDA recall Z-0954-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-20

Class II · Terminated

Class II FDA medical device recall by CoreLink LLC, initiated 2022-10-20, terminated 2024-08-20. It names one FDA 510(k) clearance: K171519. Product: CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208. Reason: Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy..

Recalling firm: CoreLink LLC
Classification: Class II
Status: Terminated
Initiated: 2022-10-20
Terminated: 2024-08-20
Firm location: Fenton, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K171519 — FLXfitExpanding Orthopedics, Inc.·cleared 2017-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.