Recall Z-1290-2018 ยท FZP Clip, Implantable
Aesculap Implant Systems LLC
DS Titanium Ligation Clip, used in laparoscopic surgery
| Date | Jan 22, 2018 |
| Status | Terminated |
| Reason | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm. |
| Root cause | Labeling design |
| Action | A letter and copy of the updated IFU was sent to affected customers the week of January 15, 2018. Product does not need to be returned. IFU is revised and put on the Aesculap Website for usage. https://www.aesculapusa.com/products/instructions-for-use. |
| Quantity | 9621 |
| Distribution | US and Canada distribution |
| FDA record | Open on fda.gov |