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U.S. Department of Health and Human Services

Class 2 Device Recall Push Brace for Mechanical Chair

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 Class 2 Device Recall Push Brace for Mechanical Chairsee related information
Date Initiated by FirmDecember 08, 2021
Create DateFebruary 08, 2022
Recall Status1 Terminated 3 on September 05, 2023
Recall NumberZ-0569-2022
Recall Event ID 89236
Product Classification Chair, adjustable, mechanical - Product Code INN
ProductR82 by ETAC Push Brace for High-Low
Code Information Model No. 8910545, Manufactured from 08/09/2021-10/03/2021
FEI Number 3001657382
Recalling Firm/
Manufacturer		 R82 A/S
Parallelvej 3
Gedved Denmark
For Additional Information ContactUlla Lange
4579685888
Manufacturer Reason
for Recall		The chrome surface of the push brace can crack during use, potentially cutting the user.
FDA Determined
Cause 2		Process control
ActionA notification dated 12/10/2021 was sent to customers by R82 A/S notifying them of a Field Safety Notice concerning Push Brace 8910545 attached to patient mobility chairs. The notice communicates the chrome surface's potential for cracking during use, posing a risk of cutting the caregiver utilizing the push brace. The firm instructs customers to visually inspect recalled push braces before use and should be disposed of if any are detected. The firm also communicated that customers with affected push braces will receive replacements. If product has been further distributed, the notice needs to be forwarded on.
Quantity in Commerce396 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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