Recall Z-1781-2013 ยท GXH Device, Surgical, Cryogenic
Myoscience Inc
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 p
| Date | Jul 20, 2013 (initiated Jun 21, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 3 units |
| Distribution | US distribution including CA and ID. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123516 | CRYO-TOUCH IV Myoscience, Inc., Jan 10, 2013 |