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U.S. Department of Health and Human Services

Class 2 Device Recall Signia Power Handle

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  Class 2 Device Recall Signia Power Handle see related information
Date Initiated by Firm December 13, 2017
Create Date March 27, 2018
Recall Status1 Open3, Classified
Recall Number Z-1237-2018
Recall Event ID 79483
510(K)Number K160176  
Product Classification Staple, implantable - Product Code GDW
Product Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits)

The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Code Information SIGPHANDLE-UDI 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Recalling Firm/
Manufacturer
Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
203-492-5000
Manufacturer Reason
for Recall
Product reportedly shutting down during use.
FDA Determined
Cause 2
Component design/selection
Action The firm, Medtronic, sent a "Field Corrective Action Notice" dated 12/13/2017 to all consignees via Federal Express or certified mail on 12/13/17. The notice described the product, problem and actions to be taken. Customers were instructed to: immediately notify all users of Signia power handles of this important notification; follow the User manual and Instructions for Use; If your facility has distributed Signia" power handles to other persons or facilities, please promptly forward a copy of this letter to those recipients, and complete and return the Field Corrective Action Acknowledgement Form via Fax to (203) 492-7719 or email to: FCAMITG@Medtronic.com. All in-control inventory and product at customers locations will have the software update installed. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 2121
Distribution Worldwide Distribution: US (Nationwide).
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
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