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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 Recall
Endoplus Single Action Insert
see related information
Date Posted September 21, 2013
Recall Status1 Open
Recall Number Z-2264-2013
Recall Event ID 66063
Premarket Notification
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, Illinois 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = ENDO TECHNIC CORP.
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