Recall Z-1520-2011 · L
ConMed Corporation
VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5" x 12" 12-page booklet and is packed loose in the carton. Only the carton will have to be opened to replace the old IFU; there is no need to open the sterile packaging of the individual VCare pouches. The ConMed VCARE Retrac
| Date | Mar 3, 2011 (initiated Feb 2, 2011) |
| Status | Terminated |
| Reason | Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning Note 6 to the VCare Instructions for Use. The reason for the field correction is to provide a copy of the revised IFU to all customers who may have unexpired Vcare |
| Root cause | Device Design |
| Action | ConMed Corporation sent a communication to provide its direct consignees with important supplemental information concerning the Instructions for Use (IFU) for the VCARE Vaginal-Cervical Ahluwalia's Retractor-Elevator uterine manipulators. The direct consignees were instructed to place a copy of the enclosed Instructions for Use, Part No. 14071 (Rev. A), with any inventory in your possession with an expiration date prior to August 2011 (2011-08) and replace any other Instructions for Use in thier possession. A copy of the enclosed Instructions for Use is already packaged with all devices bear |
| Quantity | 31,028 VCare¿ Vaginal-Cervical Ahluwalia's Retractor-Elevator devices |
| Distribution | Worldwide Distribution - USA including NY, TX, CA, IA, AZ, PA, IN, and KS and the countries of Austria, Jordan, Turkey, China, Portugal, Chile, Belgium, Ecuador, Brazil, Romania, Japan, Malaysia, India Switzerland, Colombia, Netherlands, Spain, Saudi Arabia, France, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071907 | VCARE RETRACTOR/ELEVATOR Conmed Corporation, Oct 5, 2007 |