Reported Jun 13, 2018 · Terminated
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev.…
MicroAire Surgical Instruments, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MicroAire Surgical Instruments, LLC · 3590 Grand Forks Blvd · Charlottesville, VA · 22911-9006
Is this the product you have?
- MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
- Lot codes and dates
- All products distributed from 1/1/13 to 2/23/18
- Amount recalled
- 2009
Where it was sold
- Nationwide
- PR
Why it was recalled
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
This product could cause temporary or reversible health problems — stop using it.
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