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.
FDA Recall Z-2265-2013 · Posted 2013-09-21
Recalling FirmEndoplus, Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2013-07-15
Date Terminated2016-02-08
Product Quantity9 units
Reason for Recall
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Firm Action
Letters were sent on 7/15/2013 to all customers notifying them of the recall. The letters requested that customers return the recalled devices via private courier using an enclosed account number. Replacement devices will be made available upon customer request.
Root Cause
Process control
Distribution Pattern
Distributed in the states of FL, TX, and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.