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U.S. Department of Health and Human Services

Class 2 Device Recall LeMaitre Vascular AnastoClip Universal Clip Remover

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  Class 2 Device Recall LeMaitre Vascular AnastoClip Universal Clip Remover see related information
Date Initiated by Firm June 22, 2016
Create Date July 25, 2016
Recall Status1 Terminated 3 on April 08, 2021
Recall Number Z-2288-2016
Recall Event ID 74563
510(K)Number K962043  
Product Classification Clip, implantable - Product Code FZP
Product AnastoCiip Universal Clip Remover (6 Pack}
REF# e4001-00

The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Code Information Lot Numbers: ANR1067¿ ANR1072¿ ANR1073¿ ANR1074¿ 
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact SAME
781-221-2266
Manufacturer Reason
for Recall		 US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the reply form for reconciliation of this recall via fax at 781-221-2223, email: CSUS@LEMAITRE.COM or by mail. LeMaitre Vascular, Inc. will replace any affected device with a new device labeled for dura closure or issue a credit per request. Questions concerning this safety notice, please contact me at 781-221-2266 ext. 183.
Quantity in Commerce 55 units (6 pack)
Distribution US Nationwide Distribution
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 = FZP and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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