# FDA recall Z-0591-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-10-10.

## Product

Comprehensive Mini Stem, Item No. 113631:

## Reason for recall

Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

## Distribution

Distributed to accounts in IN, MD, MO, MS, and NM.

## Key facts

- **Recall number:** Z-0591-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-10
- **Report date:** 2018-12-19
- **Termination date:** 2020-04-28

- **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-0591-2019

## Citation

> AI Analytics. FDA recall Z-0591-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0591-2019. Source: US FDA. Licensed CC0.

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