R82 by ETAC Push Brace for High-Low
FDA Recall #Z-0569-2022 — Class II — December 8, 2021
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.
Recalling Firm
R82 A/S — Gedved, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Model No. 8910545, Manufactured from 08/09/2021-10/03/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated