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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 Device Recall Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device see related information
Date Initiated by Firm September 25, 2013
Date Posted December 06, 2013
Recall Status1 Completed
Recall Number Z-0458-2014
Recall Event ID 66627
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 NJ 08876
For Additional Information Contact
877-384-4266
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.
FDA Determined
Cause 2
Unknown/Undetermined by firm
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 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.
510(K) Database 510(K)s with Product Code = NEW and Original Applicant = ETHICON, INC.
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