Z-2107-2018 Class II Terminated
FDA device recall Z-2107-2018 was initiated by MicroAire Surgical Instruments, LLC on April 19, 2018 and is designated Class II. Reason for recall: The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced. The recall status is terminated (terminated April 10, 2020). Affected quantity: 2009.
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- April 19, 2018
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2009
Product Description
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).
Reason for Recall
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
Code Information
All products distributed from 1/1/13 to 2/23/18