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.
Recall
- Recall Number
- Z-1781-2013
- Event Number
- 65542
- Firm
- Myoscience Inc
- FEI Number
- 3009131456
- Product Code
- GXH
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- June 21, 2013
- Posted
- July 20, 2013
- Terminated
- July 15, 2014
- Address
- 1600 Seaport Blvd, Suite 450, Redwood City, CA, 94063-5563
Description
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.
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.
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.
US distribution including CA and ID.
3 units