# FDA recall Z-2528-2026

> **Zimmer, Inc.** · Class II · device recall initiated 2026-05-20.

## Product

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide  Model/Catalog Number: 110040241

## Reason for recall

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2528-2026
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-20
- **Report date:** 2026-07-01

- **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-2528-2026

## Citation

> MORVS. FDA recall Z-2528-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2528-2026. Source: US FDA. Licensed CC0.

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