Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall A LiGator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall A LiGatorsee related information
Date Initiated by FirmSeptember 17, 2020
Create DateOctober 30, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0310-2021
Recall Event ID 86412
510(K)NumberK030269 
Product Classification Clip, implantable - Product Code FZP
ProductA 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  
FEI Number 3002590791
Recalling Firm/
Manufacturer		 Genicon, Inc.
6869 Stapoint Ct Ste 112
Winter Park FL 32792-6603
For Additional Information ContactMarianne 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
ActionOn 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 Commerce8,872 devices
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = FZP
-
-