FDA Medical Device Recalls (openFDA)
R82 A/S: R82 by ETAC Push Brace for High-Low
- Recall number
- Z-0569-2022
- Recalling firm
- R82 A/S
- Product
- R82 by ETAC Push Brace for High-Low
- Status
- Terminated
- Initiated
- 2021-12-08
- Posted
- not on file
- Terminated
- 2023-09-05
- Reason
- The chrome surface of the push brace can crack during use, potentially cutting the user.
- Root cause
- Process control
- Action
- A notification dated 12/10/2021 was sent to customers by R82 A/S notifying them of a Field Safety Notice concerning Push Brace 8910545 attached to patient mobility chairs. The notice communicates the chrome surface's potential for cracking during use, posing a risk of cutting the caregiver utilizing the push brace. The firm instructs customers to visually inspect recalled push braces before use and should be disposed of if any are detected. The firm also communicated that customers with affected push braces will receive replacements. If product has been further distributed, the notice needs to be forwarded on.
- 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.
- Lot, serial or model codes
- Model No. 8910545, Manufactured from 08/09/2021-10/03/2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- INN
- Firm FEI
- 3001657382
- Firm city
- Gedved
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28