Skip to content
Recall Observatory FDA recall evidence

Device product

R82 by ETAC Push Brace for High-Low

Z-0569-2022

December 08, 2021

Class II

Product summary

Firm
R82 A/S
Event
Event 89236
Status
Terminated
Classification
Class II
Quantity
396 units
Official record key
device-enforcement:Z-0569-2022

Official wording

Reason: The chrome surface of the push brace can crack during use, potentially cutting the user.

Code information: Model No. 8910545, Manufactured from 08/09/2021-10/03/2021

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The chrome surface of the push brace can crack during use, potentially cutting the user.