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
|