Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX Intended Usage: The grasper is indicated

FDA device recall Z-2987-2011 · posted 2011-08-10 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GCJ

Quantity affected

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,

Date initiated

2011-06-17

Date posted

2011-08-10

Date terminated

2012-03-26

Location

Rancho Santa Margarita, CA