Recall Z-1781-2013
Myoscience Inc · initiated June 21, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Numbers: 100100, 100101, 100103
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: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-1781-2013
- Initiated
- June 21, 2013
- Posted by FDA
- July 20, 2013
- Terminated
- July 15, 2014
- Product code
- GXH – Device, Surgical, Cryogenic
- Quantity
- 3 units
- Distribution
- US distribution including CA and ID.
- Recalling firm
- Myoscience Inc, Redwood City, CA