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U.S. Department of Health and Human Services

Class 2 Device Recall MicroAire SmartRelease Endoscopic System

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  Class 2 Device Recall MicroAire SmartRelease Endoscopic System see related information
Date Initiated by Firm April 19, 2018
Date Posted May 25, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-2107-2018
Recall Event ID 80095
510(K)Number K912871  
Product Classification Arthroscope - Product Code HRX
Product 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).
Code Information All products distributed from 1/1/13 to 2/23/18
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9006
For Additional Information Contact
800-722-0822
Manufacturer Reason
for Recall		 The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 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, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = 3M HEALTH CARE, LTD.
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