Device recall

Z-1781-2013: Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic…

FDA device recall · Class II · Myoscience Inc

Key facts

Recall number (Z-number) Z-1781-2013
Recall event 65542
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…
Product code GXH
Recalling firm Myoscience Inc
Recall class Class II
Status Terminated
Termination date Jul 15, 2014
510(k) numbers K123516
FEI number 3009131456

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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