Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 OR C4140 Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.

The recall was initiated because Applied Medical has confirmed specific lot numbers of the Direct Drive Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger, which could result in the trigger fracturing and the jaw locking in the closed position.

Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 22, to all affected consignees. The letter described the product, problem and actions to be taken. Consignees were instructed to check their inventory for the recalled products and returned immediately as per the instructions. The letter instructs consignees to complete the attached Voluntary Recall Notification Confirmation Form and fax it to Regulatory Affairs at 949-713-8832 or email it to [email protected]. For questions pertaining to product return contact Chris Jacobson, Sales Operations Administrator, at (949) 713-8652 or by email at [email protected]. For regulatory questions contact Susan Fehrenbacher at (949) 713-8041 or by email at [email protected].