Recall Z-2578-2021 ยท FZP Clip, Implantable
Aesculap Implant Systems LLC
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
| Date | Apr 16, 2021 |
| Status | Terminated |
| Reason | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery |
| Root cause | Under Investigation by firm |
| Action | Aesculap issued An Urgent Medical Device Recall notification via USPS overnight to consignees on April 16, 2021. Letter states reason for recall, health risk and action to take: Immediately examine your inventory, identify and quarantine product related to this notification recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this Recall Notification. Your notification to your customers may be enhanced by including a copy of this notification letter. 1. Review the PAS-PORT Proximal Anastomosis System Recall Notification i |
| Quantity | 80 units |
| Distribution | US Nationwide distribution in the states of FL, MI, NY, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202124 | Aesculap PAS-Port Proximal Anastomosis System Aesculap, Inc., Sep 2, 2020 |