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U.S. Department of Health and Human Services

Class 2 Device Recall VCARE

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  Class 2 Device Recall VCARE see related information
Date Initiated by Firm September 08, 2008
Date Posted October 28, 2008
Recall Status1 Terminated 3 on August 29, 2012
Recall Number Z-0176-2009
Recall Event ID 49406
510(K)Number K071907  
Product Classification Cannula - Product Code LFK
Product VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-001. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE¿ Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
Code Information Lots 0710121x through and including 0804111x [yymmddx where x = shift code 1,2, or 3] . All lots of the recalled devices were manufactured between and including October 12, 2007 and April 11, 2008.
Recalling Firm/
ConMed Corporation
525 French Road
Utica NY 13502
For Additional Information Contact Ms. Patricia Cotter
Manufacturer Reason
for Recall
The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
FDA Determined
Cause 2
Process change control
Action The domestic recall notices were mailed on 9/08/08 by USP Priority Mail pouches. The international notices were sent via FedEx International Priority on 9/08/08. The letter described the problem, the health risk and requested that customers inventory the product and return them back to the firm. Customers are requested to fax the reply form to the firm. Contact ConMed Corporation at 1-800-765-8375, ext 3237 for assistance.
Quantity in Commerce 32,453 (total devices)
Distribution Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
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 = LFK and Original Applicant = CONMED CORPORATION