# FDA recall Z-2300-2020

> **Biomet, Inc.** · Class II · device recall initiated 2020-05-11.

## Product

Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503  (10)814100, (01)00880304829503  (10)570640, (01)00880304829503  (10)728890, (01)00880304829503  (10)977300

## Reason for recall

The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.

## Distribution

US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.

## Key facts

- **Recall number:** Z-2300-2020
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-11
- **Report date:** 2020-06-17
- **Termination date:** 2020-11-04

- **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-2300-2020

## Citation

> AI Analytics. FDA recall Z-2300-2020. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2300-2020. Source: US FDA. Licensed CC0.

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