Medical device recalls Moderate risk

R82 A/S recalls R82 by ETAC Push Brace for High-Low

Recall date
December 8, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0569-2022
FDA classification
Class II
Brand / firm
R82 A/S
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

R82 by ETAC Push Brace for High-Low

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