R82 A/S: Medical Device Recall in 2022 - (Recall #: Z-0569-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

R82 by ETAC Push Brace for High-Low

Product Classification:

Class II

Date Initiated: December 8, 2021
Date Posted: February 16, 2022
Recall Number: Z-0569-2022
Event ID: 89236
Reason for Recall:

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

Status: Terminated
Product Quantity: 396 units
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.

Voluntary or Mandated:

Voluntary: Firm initiated