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U.S. Department of Health and Human Services

Class 2 Device Recall staple, implantable

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  Class 2 Device Recall staple, implantable see related information
Date Initiated by Firm September 15, 2017
Create Date March 06, 2018
Recall Status1 Terminated 3 on December 19, 2018
Recall Number Z-0908-2018
Recall Event ID 79166
510(K)Number K132493  
Product Classification Staple, implantable - Product Code GDW
Product Endo GIA" Radial Reload with Tri-Staple" Technology

The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Information Product number: EGIARADXT Lot code: N6L0351X
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Catherine T. Wrenn
203-492-5000
Manufacturer Reason
for Recall		 The device cartridge disengaged during use due to manufacturing error.
FDA Determined
Cause 2		 Process control
Action Medtronic sent an "URGENT MEDICAL RECALL LETTER" dated September 13, 2017, was issued to customers titled "Covidien Endo GIA Black Radial Reload with Tri-Staple Technology" urging customers to quarantine and return unused product to recalling firm. Questions or concerns can be directed to: feedback.customerservice@Covidien.com. For further questions, please call (203) 492-5000.
Quantity in Commerce 163
Distribution Internationally, including Japan. No USA Customers
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 = GDW and Original Applicant = Covidien LLC
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