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U.S. Department of Health and Human Services

Class 2 Device Recall PROLIFT

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 Class 2 Recall
PROLIFT
see related information
Date Posted May 10, 2007
Recall Status1 Terminated on March 04, 2008
Recall Number Z-0795-2007
Recall Event ID 37805
Premarket Notification
510(K) Number
K013718 
Product Classification Mesh, Surgical - Product Code FTM
Product Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
Code Information Product Code PFRT01 Lot Number 2990052 2007-12
Recalling Firm/
Manufacturer
Ethicon, Inc.
US Highway 22 West
Somerville, New Jersey 08876
For Additional Information Contact Christiana Bielinski
908-253-2553
Manufacturer Reason
for Recall
The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers.
Quantity in Commerce 160 units to US
Distribution Nationwide
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
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 = FTM and Original Applicant = GYNECARE, A DIV. OF ETHICON, INC.
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