Recall Z-1781-2013— Myoscience Inc

Name: FDA recall Z-1781-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-21

Class II · Terminated

Class II FDA medical device recall by Myoscience Inc, initiated 2013-06-21, terminated 2014-07-15. It names one FDA 510(k) clearance: K123516. 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.. 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..

Recalling firm: Myoscience Inc
Classification: Class II
Status: Terminated
Initiated: 2013-06-21
Terminated: 2014-07-15
Firm location: Redwood City, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123516 — CRYO-TOUCH IVMyoscience, Inc.·cleared 2013-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.