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U.S. Department of Health and Human Services

Class 2 Device Recall iovera Smart Tip

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  Class 2 Device Recall iovera Smart Tip see related information
Date Initiated by Firm July 01, 2015
Date Posted July 22, 2015
Recall Status1 Terminated 3 on September 08, 2015
Recall Number Z-2201-2015
Recall Event ID 71650
510(K)Number K142866  
Product Classification Device, surgical, cryogenic - Product Code GXH
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
Code Information Catalog numbers:STT0412-¿10 and STT0412-¿5;  Lot numbers : 1504021-¿01 and 1505008.
Recalling Firm/
Manufacturer		 Myoscience Inc
46400 Fremont Blvd
Fremont CA 94538-6469
For Additional Information Contact Tracey Henry
510-933-1510
Manufacturer 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.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500.
Quantity in Commerce 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.
Distribution US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXH and Original Applicant = Myoscience, Inc
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