FDAFDA · Food and drugs·Recall number Z-1781-2013
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.
Published July 31, 2013 · Recall initiated: June 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Myoscience Inc
- Distributor
- US distribution including CA and ID.
- Lot
- Serial Numbers: 100100, 100101, 100103
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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