FDA-Device2024-04-17Class II
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
Hazard
Medical device components were marketed without FDA clearance
Sold states
US Nationwide distribution in the state of WA.
Affected count
1681 units
Manufactured in
1501 N Harbor Blvd Ste 209, N/A, Fullerton, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief