Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manip

FDA device recall Z-1521-2013 · posted 2013-06-07 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;

Action taken

Applied Medical notified customers of the recall beginning on May 13, 2013. The "URGENT: MEDICAL DEVICE RECALL" letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact the firm at (949) 713-8041.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NWV

Quantity affected

127,305 units

Distribution

Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, I

Date initiated

2013-05-01

Date posted

2013-06-07

Date terminated

2014-02-06

Location

Rancho Santa Margarita, CA