MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev.
FDA device recall Z-2107-2018 · posted 2018-05-25 · Terminated
Recall details
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Reason for recall
- The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
- Action taken
- Urgent Medical Device Recall letters were distributed to customers. The letters instructed customers to do the following: If you have some quantity of IFUs remaining, we're asking you to destroy your current copies, IM-SMARTRELEASE Rev. A-D, and replace them by going on-line at MicroAire at www.microaire.com/resources. Click Carpal Tunnel, then SmartRelease Instruction Manual to obtain the latest version, IM-SMARTRELEASE Rev. E. Please complete and send back page two of this letter to notification@microaire.com or via fax at 800-648-4309. If you have no quantity of IFUs remaining, there are no further activities needed by you except for the mandatory returning of page two of this letter to notification@microaire.com or via fax at 800-648-4309. For further questions, please call (800) 722-0822.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 2009
- Distribution
- 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, Ir
- Date initiated
- 2018-04-19
- Date posted
- 2018-05-25
- Date terminated
- 2020-04-10
- Location
- Charlottesville, VA
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Related 510(k) clearances
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| INSIDE JOB (K912871) | 3M Health Care, Ltd. | 1991-08-09 |