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Terminated

R82 by ETAC Push Brace for High-Low

FDA Recall Z-0569-2022 · Posted None

Recalling FirmR82 A/S
Recall StatusTerminated
Product CodeINN
Date Initiated2021-12-08
Date Terminated2023-09-05
Product Quantity396 units

Reason for Recall

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

Firm Action

A 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.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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