# FDA recall Z-1615-2020

> **Biomet, Inc.** · Class II · device recall initiated 2020-02-25.

## Product

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency  Item Number: 010000589

## Reason for recall

Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

## Distribution

International distribution - country of Netherland.s

## Key facts

- **Recall number:** Z-1615-2020
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-25
- **Report date:** 2020-04-08
- **Termination date:** 2020-08-05

- **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-1615-2020

## Citation

> AI Analytics. FDA recall Z-1615-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1615-2020. Source: US FDA. Licensed CC0.

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