Class II — R82 A/S
| Recalling firm | R82 A/S |
|---|---|
| Registered facility | R82 A/S (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The chrome surface of the push brace can crack during use, potentially cutting the user. |
| Product | R82 by ETAC Push Brace for High-Low |
| Quantity | 396 units |
| 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. |
| Initiated | 2021-12-08 |
| Classified | 2022-02-08 |
| Terminated | 2023-09-05 |
| Recall number | Z-0569-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — R82 A/S (Z-0569-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89236/
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