FDA recall Z-1498-2024

Product

Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052

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-1498-2024