Z-0310-2021Class II

A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm -

Name: Z-0310-2021 A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm -
Creator: Genicon, Inc.
Published: 2020-09-17
License: https://open.fda.gov/license/

Genicon, Inc. / initiated 2020-09-17 / Open, Classified / root cause: manufacturing process

FDA source

Genicon, Inc. began a recall of 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... on 2020-09-17. FDA classified it as Class II and gives the reason as "Device malfunction causing the applier to jam, and clip loading failures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0310-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-17
Posted: 2020-10-30
Recalling firm: Genicon, Inc.
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
Product code: FZP Clip, Implantable
Reason for recall: Device malfunction causing the applier to jam, and clip loading failures.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0310-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0310-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-10-30

Product code FZP

K030269Class IIGenicon Clip ApplierGenicon, LC / cleared 2003-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)