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U.S. Department of Health and Human Services

Class 2 Device Recall Endoplus Single Action Insert

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  Class 2 Device Recall Endoplus Single Action Insert see related information
Date Initiated by Firm July 15, 2013
Date Posting Updated September 21, 2013
Recall Status1 Terminated 3 on February 08, 2016
Recall Number Z-2264-2013
Recall Event ID 66063
510(K)Number K925079  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic 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.
Code Information Item: 346VA; , Lot Numbers: D3, E3, F3
Recalling Firm/
Manufacturer
Endoplus, Inc.
750 Tower Rd
Suite A
Mundelein IL 60060-3818
For Additional Information Contact Matthew Gudeman
847-325-5660
Manufacturer Reason
for Recall
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
FDA Determined
Cause 2
Process control
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.
Quantity in Commerce 81 units
Distribution Distributed in the states of FL, TX, and VA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = ENDO TECHNIC CORP.
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