# FDA recall Z-0979-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-12-08.

## Product

Humeral Stem 83mm(Size 17)    Product Usage:  Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

## Reason for recall

Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

## Distribution

US Nationwide in the states of MN, NJ, CA, TX, ND

## Key facts

- **Recall number:** Z-0979-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-08
- **Report date:** 2018-03-21
- **Termination date:** 2018-09-04

- **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-0979-2018

## Citation

> AI Analytics. FDA recall Z-0979-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0979-2018. Source: US FDA. Licensed CC0.

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