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U.S. Department of Health and Human Services

Class 2 Device Recall Multifire VersaTrack

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  Class 2 Device Recall Multifire VersaTrack see related information
Date Initiated by Firm May 12, 2020
Create Date June 03, 2020
Recall Status1 Open3, Classified
Recall Number Z-2253-2020
Recall Event ID 85689
510(K)Number K912097  
Product Classification Laryngoscope, endoscope - Product Code GCI
Product Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
Code Information Lots P9J1172Y  P9K0452Y  P9K0453Y  P9K0454Y  P9K1596Y  P0B0996Y  
Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Medtronic Post Market Vigilance
508-261-8000
Manufacturer Reason
for Recall		 The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
FDA Determined
Cause 2		 Process control
Action All consignees were notified by letter titled "Urgent Medical Device Recall" delivered via Federal Express and/or certified mail beginning May 12, 2020. The letter informs customers of the recall of specific item codes and production lots of Multifire hernia staplers due to a manufacturing assembly error. Use of a device with this condition may result in the failure of staples to properly advance within the staple cartridge when the instrument handle is compressed. Customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected product. " Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions about this event, you may contact Medtronic via email at rs.assurancequality@medtronic.com
Quantity in Commerce 12,610 total
Distribution Worldwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GCI and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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