# FDA recall Z-1985-2026

> **DEPUY (IRELAND)** · Class II · device recall initiated 2026-04-03.

## Product

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

## Reason for recall

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

## Distribution

US Nationwide distribution in the states of MN, NC, TX.

## Key facts

- **Recall number:** Z-1985-2026
- **Recalling firm:** DEPUY (IRELAND)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-03
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Co. Cork, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1985-2026

## Citation

> AI Analytics. FDA recall Z-1985-2026. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1985-2026. Source: US FDA. Licensed CC0.

---

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