Recall Z-0569-2022— R82 A/S
Class II · Terminated
Class II FDA medical device recall by R82 A/S, initiated 2021-12-08, terminated 2023-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: R82 by ETAC Push Brace for High-Low. Reason: The chrome surface of the push brace can crack during use, potentially cutting the user..
- Recalling firm
- R82 A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-08
- Terminated
- 2023-09-05
- Firm location
- Gedved, N/A, Denmark
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.