Recall Z-1291-2018 ยท FZP Clip, Implantable
Aesculap Implant Systems LLC
DS Titanium Ligation Clip Appliers, 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. Updated cleaning and sterilization instructions. |
| 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 | 270 |
| Distribution | US and Canada distribution |
| FDA record | Open on fda.gov |