# FDA recall Z-1216-2022

> **Tornier, Inc** · Class II · device recall initiated 2022-05-03.

## Product

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

## Reason for recall

The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1216-2022
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-03
- **Report date:** 2022-06-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2022

## Citation

> AI Analytics. FDA recall Z-1216-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1216-2022. Source: US FDA. Licensed CC0.

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