Z-1781-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2013
- Initiation Date
- June 21, 2013
- Termination Date
- July 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product 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.
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.
Distribution Pattern
US distribution including CA and ID.
Code Information
Serial Numbers: 100100, 100101, 100103