VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60-6085-002. Made in USA, CONMED
FDA device recall Z-0177-2009 · posted 2008-10-28 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- 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.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LFK
- Quantity affected
- 32,453 (total devices)
- Distribution
- Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
- Date initiated
- 2008-09-08
- Date posted
- 2008-10-28
- Date terminated
- 2012-08-29
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VCARE RETRACTOR/ELEVATOR (K071907) | Conmed Corporation | 2007-10-05 |