Summary
The FDA issued a Class II for R82 by ETAC Push Brace for High-Low by R82 A/S. Reason: The chrome surface of the push brace can crack during use, potentially cutting the user..
Details
Source
Device Recall
External ID
Z-0569-2022
Action Date
2022-02-16
Status
Terminated
Category
device
Product Description
R82 by ETAC Push Brace for High-Low
Lot/Code Info: Model No. 8910545, Manufactured from 08/09/2021-10/03/2021
Quantity Affected: 396 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-08
Company
Gedved, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (R82 A/S) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does R82 A/S have FDA actions?
This is the only FDA action we have on record for R82 A/S in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0569-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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