Recall Z-0656-2020 ยท FZP Clip, Implantable
Ethicon Endo-Surgery Inc
Ligamax 5 mm Endoscopic Multiple Clip Applier
| Date | Nov 7, 2019 |
| Status | Terminated |
| Reason | A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility. |
| Root cause | Under Investigation by firm |
| Action | On November 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE RECALL (REMOVAL) LIGAMAX 5mm Endoscopic Multiple Clip Applier Product Codes: EL5ML (Multiple Lot Numbers) Dear Valued Customer Ethicon has initiated a voluntary medical device recall (removal) of specific lots of LIGAMAX 5mm Endoscopic Multiple Clip Applier. Ethicon identified that a potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility. In the event that the |
| Quantity | 48,428 |
| Distribution | US: Nationwide International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110699 | LIGAMAX 5 Ethicon Endo-Sugery, LLC, Mar 25, 2011 |