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U.S. Department of Health and Human Services

Class 2 Device Recall Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device

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 Class 2 Recall
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device
see related information
Date Posted December 06, 2013
Recall Status1 Open
Recall Number Z-0458-2014
Recall Event ID 66627
Premarket Notification
510(K) Number
K113004 
Product Classification Suture, Surgical, Absorbable, Polydioxanone - Product Code NEW
Product Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
Code Information K113004 D183642 All product codes beginning with SXPP1A.
Recalling Firm/
Manufacturer
Ethicon, Inc.
US Highway 22 West
Somerville, New Jersey 08876
Manufacturer Reason
for Recall
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Action Ethicon Inc. sent recall notifications/business reply forms on 9/25/2013 via UPS next day certified mail.
Quantity in Commerce 37,164 eaches
Distribution Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
Total Product Life Cycle TPLC Device Report

 
1 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 = NEW and Original Applicant = ETHICON, INC.
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