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U.S. Department of Health and Human Services

Class 2 Device Recall TriStaple" 2.0 Black Reinforced Intelligent Reload

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 Class 2 Device Recall TriStaple" 2.0 Black Reinforced Intelligent Reloadsee related information
Date Initiated by FirmApril 15, 2024
Date PostedMay 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1891-2024
Recall Event ID 94484
510(K)NumberK173270 
Product Classification Staple, implantable - Product Code GDW
ProductTri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Code Information GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Recalling Firm/
Manufacturer
Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactKati Salefski
508-452-4894
Manufacturer Reason
for Recall
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
FDA Determined
Cause 2
Under Investigation by firm
ActionMedtronic issued Urgent Medical Device Recall letter on 4/15/24 via UPS 2-day. Letter states reason for recall, health risk and action to take: Customer Actions: " Immediately identify and quarantine all unused Tri-Staple" 2.0 Black Reinforced Intelligent Reload, Model SIGTRSB60AXT, from the specified lot(s) mentioned above. " Return all unused product in your inventory, corresponding to the specified lot(s) mentioned above, to Medtronic as indicated in the enclosed Customer Confirmation Form. Please complete the enclosed Customer Confirmation Form, even if you have no product to return. Pass on this information to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please keep a copy of this letter in your file. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.
Quantity in Commerce1681 units
DistributionWorldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
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