R82 by ETAC Push Brace for High-Low — Class II medical device recall Z-0569-2022
Terminated recall by R82 A/S, reported 2022-02-16, distributed nationwide. The chrome surface of the push brace can crack during use, potentially cutting the user.
| Recall number | Z-0569-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | R82 A/S, Gedved, N/A, Denmark |
| Recall initiated | 2021-12-08 |
| Classified | 2022-02-08 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2023-09-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, DE, FI, GB, GR, IT, JP, NL, NO, PL, RU, SE |
| Quantity | 396 units |
| Reason classes | packaging |
| Model numbers | 8910545 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0569-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.