FDA Medical Device Recalls (openFDA)
ConMed Corporation: VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-101. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502.
- Recall number
- Z-0179-2009
- Recalling firm
- ConMed Corporation
- Product
- VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-101. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502.
- Status
- Terminated
- Initiated
- 2008-09-08
- Posted
- 2008-10-28
- Terminated
- 2012-08-29
- Reason
- 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.
- Root cause
- 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
- 32,453 (total devices)
- Distribution
- Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K955446"]
- PMA numbers
- not on file
- Product code
- LFK
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28