# FDA recall Z-1497-2024

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

## 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

- **Recall number:** Z-1497-2024
- **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-1497-2024

## Citation

> AI Analytics. FDA recall Z-1497-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1497-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*