Z-0569-2022Class II

R82 by ETAC Push Brace for High-Low

Name: Z-0569-2022 R82 by ETAC Push Brace for High-Low
Creator: R82 a/s
Published: 2021-12-08
License: https://open.fda.gov/license/

R82 a/S / initiated 2021-12-08 / Terminated / root cause: manufacturing process

FDA source

R82 A/S began a recall of R82 by ETAC Push Brace for High-Low on 2021-12-08. FDA classified it as Class II and gives the reason as "The chrome surface of the push brace can crack during use, potentially cutting the user". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0569-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-08
Posted: 2022-02-08
Terminated: 2023-09-05
Recalling firm: R82 a/S
Product: R82 by ETAC Push Brace for High-Low
Product code: INN Chair, Adjustable, Mechanical
Reason for recall: The chrome surface of the push brace can crack during use, potentially cutting the user.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Model No. 8910545, Manufactured from 08/09/2021-10/03/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0569-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0569-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-08

Product code INN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)