# FDA recall Z-1496-2024

> **Synovo Production** · Class II · device recall initiated 2023-05-30.

## 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

- **Recall number:** Z-1496-2024
- **Recalling firm:** Synovo Production
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-30
- **Report date:** 2024-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fullerton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1496-2024

## Citation

> AI Analytics. FDA recall Z-1496-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1496-2024. Source: US FDA. Licensed CC0.

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