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

Recall date

October 20, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0954-2023

FDA classification

Class II

Brand / firm

CoreLink LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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