MicroAire Surgical Instruments, LLC is recalling 1,451 eaches of the SmartRelease ESTR and Onyx Blade Assembly, which is also known as the Endoscopic Carpal Tunnel Release (ECTR) System. The recall was initiated because the blade may unintentionally cut tissue before the user is ready to deploy it. No injuries have been reported at this time, but the manufacturer has voluntarily started this recall to address the potential defect.
The blade within the assembly may engage prematurely, creating a risk that surgeons could accidentally cut a patient's tissue while navigating the instrument before the intended surgical release.
Commonly known as SmartRelease Onyx.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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