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U.S. Department of Health and Human Services

Class 2 Device Recall Endo GIA Roticulator

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  Class 2 Device Recall Endo GIA Roticulator see related information
Date Initiated by Firm September 13, 2017
Date Posted February 16, 2018
Recall Status1 Open3, Classified
Recall Number Z-0636-2018
Recall Event ID 79169
510(K)Number K111825  
Product Classification Staple, implantable - Product Code GDW
Product Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Code Information N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX
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
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
FDA Determined
Cause 2
Under Investigation by firm
Action All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped.
Quantity in Commerce 3,816
Distribution Nationally
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 = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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