Synovo Production recalls ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-…

Recall date

May 30, 2023

Source

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

Recall number

Z-1496-2024

FDA classification

Class II

Brand / firm

Synovo Production

Sold / distributed

US Nationwide distribution in the state of WA.

Why it was recalled

Medical device components were marketed without FDA clearance and without FDA approval

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

What was recalled

ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566