FDA recall Z-0569-2022

Product

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

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.

Key facts

Status

Terminated

Initiation date

2021-12-08

Report date

2022-02-16

Termination date

2023-09-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gedved, N/A, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0569-2022