R82 by ETAC Push Brace for High-Low recalled due to cracking hazard
The R82 by ETAC Push Brace for High-Low is being recalled because the chrome surface can crack during use, potentially cutting users. Approximately 396 units manufactured between August and October 2021 are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a material defect (cracking) that creates a risk of cutting injury. No injuries or hospitalizations have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
The R82 by ETAC Push Brace for High-Low is a medical device used to assist users with mobility. The device is being recalled because the chrome surface can crack during normal use, which creates a cutting hazard.
The manufacturer has identified that the chrome surface may develop cracks, potentially causing injuries to users. This defect affects 396 units manufactured from August 9, 2021 to October 3, 2021.
The product has been distributed worldwide, including in the United States (North Carolina and California), and in the Czech Republic, Finland, Germany, Greece, the Netherlands, Italy, Japan, Norway, Poland, Russia, Sweden, and the United Kingdom.
If you own an R82 by ETAC Push Brace for High-Low with model number 8910545 manufactured during the affected date range, stop using the device and contact the manufacturer for replacement or repair instructions.
The recalled product
- Product
- R82 by ETAC Push Brace for High-Low
- Manufacturer
- R82 A/S
- Hazard
- Affected units
- 396
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No. 8910545
- Manufactured from 08/09/2021-10/03/2021
Distribution
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