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[Recalled] SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 — There was a higher than normal incidence rate of the blade not retracting when… | FDA 2019-06-26

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductSmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Brand / manufacturerMicroAire Surgical Instruments, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2222-2019
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date26 June 2019

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There was a higher than normal incidence rate of the blade not retracting when tightening.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from MicroAire Surgical Instruments, LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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