Z-2579-2021 Class II Terminated
FDA device recall Z-2579-2021 was initiated by Aesculap Implant Systems LLC on April 16, 2021 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated January 18, 2023). Affected quantity: 350 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- April 16, 2021
- Termination Date
- January 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 350 units
Product Description
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Code Information
All batch codes