# FDA recall Z-0569-2022

> **R82 A/S** · Class II · device recall initiated 2021-12-08.

## Product

R82 by ETAC Push Brace for High-Low

## Reason for recall

The chrome surface of the push brace can crack during use, potentially cutting the user.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of Czech Republic, Finland, Germany, Greece, Holland, Italy, Japan, Norway, Poland, Russia, Sweden, and United Kingdom.

## Key facts

- **Recall number:** Z-0569-2022
- **Recalling firm:** R82 A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-08
- **Report date:** 2022-02-16
- **Termination date:** 2023-09-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gedved, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0569-2022

## Citation

> AI Analytics. FDA recall Z-0569-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0569-2022. Source: US FDA. Licensed CC0.

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