Recall Z-2201-2015— Myoscience Inc

Name: FDA recall Z-2201-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-01

Class II · Terminated

Class II FDA medical device recall by Myoscience Inc, initiated 2015-07-01, terminated 2015-09-08. It names one FDA 510(k) clearance: K142866. Product: iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device 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 iovera device is not indicated for treatment of central nervous system tissue. Reason: The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05..

Recalling firm: Myoscience Inc
Classification: Class II
Status: Terminated
Initiated: 2015-07-01
Terminated: 2015-09-08
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K142866 — Myoscience iovera systemMyoscience, Inc.·cleared 2015-01-21

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

iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device 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 iovera device is not indicated for treatment of central nervous system tissue

Reason for recall

The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.

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