Recall Z-1278-2024 ยท HCI Applier, Aneurysm Clip
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
| Date | Mar 11, 2024 (initiated Oct 6, 2023) |
| Status | Open, Classified |
| Reason | Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip. |
| Root cause | Device Design |
| Action | Reportable Event - Removal letters dated October 6, 2023 were sent to customers. Customers were instructed to return all product subject to recall and to notify any of their customers as well. Please return items for the attention of one of the PRRCs provided to ensure quick processing and assignment to the case. If you have any questions, please contact Mr. Sven Lazic (info@lazic.de +49 (0) 7461 96643 - 20) or Ms. Kim Maier (k.maier@lazic.de or +49 (0) 7461 96643 - 21). |
| Quantity | 63 units |
| Distribution | US Nationwide distribution in the state of ME. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180757 | D-Clip; D-Clip Applier Peter Lazic GmbH, Apr 12, 2019 |