FDA recall Z-1497-2024

Product

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

Reason for recall

Medical device components were marketed without FDA clearance

Distribution

US Nationwide distribution in the state of WA.

Key facts

Status

Ongoing

Initiation date

2023-05-30

Report date

2024-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fullerton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2024