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Z-0569-2022 Class II Terminated

Recalled by R82 A/S — Gedved, N/A

FDA device recall Z-0569-2022 was initiated by R82 A/S on December 8, 2021 and is designated Class II. Reason for recall: The chrome surface of the push brace can crack during use, potentially cutting the user. The recall status is terminated (terminated September 5, 2023). Affected quantity: 396 units.

Recall Details

Product Type: Devices
Report Date: February 16, 2022
Initiation Date: December 8, 2021
Termination Date: September 5, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 396 units

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.

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.

Code Information

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