# FDA recall Z-2020-2023

> **Tornier, Inc** · Class II · device recall initiated 2023-06-12.

## Product

AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118

## Reason for recall

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.

## Key facts

- **Recall number:** Z-2020-2023
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-12
- **Report date:** 2023-07-05

- **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-2020-2023

## Citation

> AI Analytics. FDA recall Z-2020-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2020-2023. Source: US FDA. Licensed CC0.

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