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VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator)… recallZ-0175-2009 · ConMed Corporation · initiated Sep 8, 2008

Terminated All recalls posted in October 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ConMed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-0175-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 8, 2008
Posted by the FDA
Oct 28, 2008
Recalling firm
ConMed Corporation
Quantity
32,453 (total devices)
Product code
LFK
FDA submissions
K071907
Distribution
Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland

Product description

VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-000. 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 (models, lots, serial numbers)

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.

Other devices under the same FDA submission

3 devices cleared under K071907 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 49406).

Sources and updates

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