# FDA recall Z-1131-2021

> **Biomet, Inc.** · Class II · device recall initiated 2021-01-15.

## Product

Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.

## Reason for recall

Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length.   It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.

## Distribution

US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.

## Key facts

- **Recall number:** Z-1131-2021
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-15
- **Report date:** 2021-02-24
- **Termination date:** 2023-03-09

- **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-1131-2021

## Citation

> AI Analytics. FDA recall Z-1131-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-1131-2021. Source: US FDA. Licensed CC0.

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