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U.S. Department of Health and Human Services

Class 2 Device Recall A LiGator

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  Class 2 Device Recall A LiGator see related information
Date Initiated by Firm September 17, 2020
Create Date October 30, 2020
Recall Status1 Open3, Classified
Recall Number Z-0310-2021
Recall Event ID 86412
510(K)Number K030269  
Product Classification Clip, implantable - Product Code FZP
Product A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended
Code Information Model # 360-010-001 (A Li-Gator) lot codes: I8250 I8251 I8252 I8820 I8821 I8822 I8823 I8824 I8825 I9571-A I9572-A I9573-A I9716-A I9717-A I9718-A I9719-A J0113-A J0114-A J0115-A J0225-A J0227-A J0228-A J0229-A J0230-A J0231-A J0240-A J0243-A J0287-A  
Recalling Firm/
Manufacturer		 Genicon, Inc.
6869 Stapoint Ct Ste 112
Winter Park FL 32792-6603
For Additional Information Contact Marianne Feyas
407-657-4851
Manufacturer Reason
for Recall		 Device malfunction causing the applier to jam, and clip loading failures.
FDA Determined
Cause 2		 Process design
Action On 9/17/20 the firm sent a notification to its consignees with the following instructions: Your assistance is appreciated and necessary to prevent any potential harm from the use of affected product. This recall is being carried out to the user level. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification. Please complete and also encourage your customers to complete and return the enclosed response form as soon as possible. Return the form by e-mail to customerservice@geniconendo.com. In addition, if you or your customers have any of the affected devices listed in this letter, and the product is located within the United States of America, please contact Genicon (contact information listed below) to coordinate the return of the product associated with this action at no additional cost.
Quantity in Commerce 8,872 devices
Distribution Worldwide distribution - US Nationwide distribution including in the states of FL, TN, MO, CA, GA, and IN. The countries of Chile, Croatia, Dubai (UAE), Equador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Iraq, Ireland, Israel, Jordan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Palestinian, Quatar, Saudi Arabia, Slovenia, South Africa, Switzerland, Tunisia, United Kingdom, and Venezuela.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FZP and Original Applicant = GENICON, LC
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