FDA Enforcement
Class II
Terminated
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Recall: Z-2579-2021
·
Reported October 6, 2021
Enforcement
- Recall Number
- Z-2579-2021
- Event ID
- 88327
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Aesculap Implant Systems LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 6, 2021
- Initiation Date
- April 16, 2021
- Classification Date
- September 27, 2021
- Termination Date
- January 18, 2023
- Address
- 3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States
Description
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
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
Code Info
All batch codes
Distribution
US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Quantity
350 units