FDA recall Z-1496-2024

Product

ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

Reason for recall

Medical device components were marketed without FDA clearance and without FDA approval

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-1496-2024