Recall Z-2988-2011 ยท GCJ Laparoscope, General & Plastic Surgery
Applied Medical Resources Corp
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 t
| Date | Aug 10, 2011 (initiated Jun 17, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root 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 Admini |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.