Synovo Production recalls ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 0…

Recall date

May 30, 2023

Source

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

Recall number

Z-1497-2024

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

ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266