Z-2987-2011

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

Name: Z-2987-2011 Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX Intended Usage: The grasper...
Creator: Applied Medical Resources Corp
Published: 2011-06-17
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2011-06-17 / Terminated / root cause: design

FDA source

Applied Medical Resources Corp began a recall of Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX Intended Usage: The grasper is indicated for grasping and manipulating tissue... on 2011-06-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2987-2011
Status: Terminated
Initiated: 2011-06-17
Posted: 2011-08-10
Terminated: 2012-03-26
Recalling firm: Applied Medical Resources Corp
Product: Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: design
FDA 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 [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].
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.
Product codes and lots: C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX: 1109789, 1110338, 1120502, 1121622, 1122986, 1125449, 1126857, 1128330, 1128927, 1129474, 1130990, 1131764, 1132586, 1136813, 1137334, 1139969, 1141463, 1142396, 1143131.

Product code GCJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)