Date Initiated by Firm | July 15, 2013 |
Date Posted | September 21, 2013 |
Recall Status1 |
Terminated 3 on February 08, 2016 |
Recall Number | Z-2265-2013 |
Recall Event ID |
66063 |
510(K)Number | K925079 |
Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
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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. |
Code Information |
Item: 345VA; Lot Number: F3 |
Recalling Firm/ Manufacturer |
Endoplus, Inc. 750 Tower Rd Suite A Mundelein IL 60060-3818
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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 | 9 units |
Distribution | Distributed in the states of FL, TX, and VA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GCJ
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