Date Initiated by Firm | June 21, 2013 |
Date Posted | July 20, 2013 |
Recall Status1 |
Terminated 3 on July 15, 2014 |
Recall Number | Z-1781-2013 |
Recall Event ID |
65542 |
510(K)Number | K123516 |
Product Classification |
Device, surgical, cryogenic - Product Code GXH
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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 CA 94063-5563
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = GXH
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