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U.S. Department of Health and Human Services

Class 2 Device Recall PROLIFT

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  Class 2 Device Recall PROLIFT see related information
Date Initiated by Firm April 20, 2007
Date Posted May 10, 2007
Recall Status1 Terminated 3 on March 04, 2008
Recall Number Z-0795-2007
Recall Event ID 37805
510(K)Number K013718  
Product Classification Pelvic floor repair system - 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 NJ 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		 Other
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 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 = FTM and Original Applicant = GYNECARE, A DIV. OF ETHICON, INC.
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