# FDA recall Z-2363-2020

> **Biomet** · Class II · device recall initiated 2020-05-01.

## Product

Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray  Product Code: 246111003

## Reason for recall

Device and tray that houses the device did not pass steam sterilization process validation testing

## Distribution

Nationwide  Foreign: CHINA, AUSTRALIA,  CHILE,  COSTA RICA , NETHERLANDS,  SWITZERLAND

## Key facts

- **Recall number:** Z-2363-2020
- **Recalling firm:** Biomet
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-01
- **Report date:** 2020-06-24
- **Termination date:** 2021-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2363-2020

## Citation

> AI Analytics. FDA recall Z-2363-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2363-2020. Source: US FDA. Licensed CC0.

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