# FDA recall Z-1403-2025

> **ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY** · Class II · device recall initiated 2025-03-03.

## Product

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

## Reason for recall

Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

## Distribution

US distribution nationwide.  International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.

## Key facts

- **Recall number:** Z-1403-2025
- **Recalling firm:** ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-03
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oranmore, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2025

## Citation

> AI Analytics. FDA recall Z-1403-2025. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1403-2025. Source: US FDA. Licensed CC0.

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