Class 2 Device Recall Direct Drive Grasper

• Date Initiated by Firm: June 17, 2011
• Date Posted: August 10, 2011
• Recall Status: Terminated on March 26, 2012
• Recall Number: Z-2988-2011
• Recall Event ID: 59367
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: 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.
• Code Information: 1112177, 1112935, 1123914, 1126274, 1132432, 1128149, 1129688, 1132432, 1133852, 1129688, 1133852, 1135372, 1136464, 1137996, 1139978, 1141874, 1144295, 1146403, 1125156, 1125279, 1126853, 1126853, 1130549, 1111831, 1111947, 1112024, 1125131, 1135284, 1139948, 1111842, 1138635, 1143347, 1111842, 1138635, 1143347, 1125499, 1132309, 1133063, 1134258, 1137548, 1138923, 1143888, 1146663, 1111843, 1130029, 1130029, 1139271, 1139365, 1145313, 1112273, 1124108, 1127084, 1131634, 1136135, 1127363, 1125662, 1125662, 1126390, 1127004, 1128850, 1130615, 1131158, 1136058, 1136556, 1139202, 1139316, 1139316, 1139316, 1135424, 1141142, 1146443, 1147253.
• Recalling Firm/ Manufacturer: Applied Medical Resources Corp; 22872 Avenida Empresa # 3; Rancho Santa Margarita CA 92688-2650
• For Additional Information Contact: 949-713-8000
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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 recall60342148@appliedmedical.com. For questions pertaining to product return contact Chris Jacobson, Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. For regulatory questions contact Susan Fehrenbacher at (949) 713-8041 or by email at sfehrenbacker@appliedmedical.com.
• Quantity in Commerce: 38,864 units total (24,868 units in US)
• Distribution: Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.