Worldwide distribution, including USA, Dubai, Ecuador, Egypt, Germany, Holland, Indonesia, Israel, Italy, Jamaica, Kenya, Korea, Lithuania, Malaysia, Mexico, New Zealand, Norway, Qatar, Saudi Arabia, Singapore, South Africa, Sweden, Switzerland, US Virgin Islands, Canada and Belgium.
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.
Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
Description du dispositif
VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60-6085-102. 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.
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.
Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
Description du dispositif
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.
Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.
Description du dispositif
ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus¿ System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus¿ Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.
Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.
Description du dispositif
ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus¿ System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus¿ Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.