Recall Z-2265-2013— Endoplus, Inc.

Name: FDA recall Z-2265-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-15

Class II · Terminated

Class II FDA medical device recall by Endoplus, Inc., initiated 2013-07-15, terminated 2016-02-08. It names one FDA 510(k) clearance: K925079. Product: ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.. Reason: Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures..

Recalling firm: Endoplus, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-15
Terminated: 2016-02-08
Firm location: Mundelein, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K925079 — LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)Endo Technic Corp.·cleared 1994-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.

Reason for recall

Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

Data sourced from openFDA. This site is unofficial and independent of the FDA.