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U.S. Department of Health and Human Services

Class 2 Device Recall iovera

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 Class 2 Recall
iovera
see related information
Date Posted July 20, 2013
Recall Status1 Terminated on July 15, 2014
Recall Number Z-1781-2013
Recall Event ID 65542
Premarket Notification
510(K) Number
K123516 
Product Classification Device, Surgical, Cryogenic - Product Code GXH
Product Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
Code Information Serial Numbers: 100100, 100101, 100103
Recalling Firm/
Manufacturer
Myoscience Inc
1600 Seaport Blvd Suite 450
Redwood City, California 94063-5563
For Additional Information Contact Tracey Henry
650-421-0616
Manufacturer Reason
for Recall
The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Myoscience representatives visited both affected sites on June 14, 2013 and relabeled the product in person. Neither site had used the product and was unaffected by the relabeling. No formal communication was issued.
Quantity in Commerce 3 units
Distribution US distribution including CA and ID.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GXH and Original Applicant = MYOSCIENCE INC
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