Class II

Medical Device Recall: 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

Synovo Production · May 30, 2023

Reason for Recall

Medical device components were marketed without FDA clearance

Distribution

US Nationwide distribution in the state of WA.

States Affected

NATIONWIDE

Quantity Affected

1681 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1497-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.