FDAClass IIFebruary 16, 2022

R82 by ETAC Push Brace for High-Low recall

R82 by ETAC Push Brace for High-Low

Why was R82 by ETAC Push Brace for High-Low recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
R82 by ETAC Push Brace for High-Low
Recalling firm
R82 A/S
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.
Recall date
February 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls