Recall Z-0310-2021 ยท FZP Clip, Implantable
Genicon, Inc.
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
| Date | Sep 17, 2020 |
| Status | Open, Classified |
| Reason | Device malfunction causing the applier to jam, and clip loading failures. |
| 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030269 | GENICON CLIP APPLIER Genicon, LC, Mar 20, 2003 |