Synovo Production recalls Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042…

Recall date

May 30, 2023

Source

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

Recall number

Z-1498-2024

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

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

What was recalled

Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052