# FDA recall Z-1329-2025

> **Zimmer, Inc.** · Class II · device recall initiated 2025-02-12.

## Product

Z1 Femoral Hip System, Product Number 611777612

## Reason for recall

There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1329-2025
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-12
- **Report date:** 2025-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2025

## Citation

> AI Analytics. FDA recall Z-1329-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1329-2025. Source: US FDA. Licensed CC0.

---

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