Date Initiated by Firm |
September 25, 2013 |
Date Posted |
December 06, 2013 |
Recall Status1 |
Terminated 3 on May 06, 2016 |
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.
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 = NEW and Original Applicant = ETHICON, INC.
|