Z-1355-2020 Class II Terminated
FDA device recall Z-1355-2020 was initiated by Cook Inc. on January 16, 2020 and is designated Class II. Reason for recall: The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the pr… The recall status is terminated (terminated November 12, 2020). Affected quantity: 68,241.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- January 16, 2020
- Termination Date
- November 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,241
Product Description
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Reason for Recall
The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information.
Distribution Pattern
Foreign distribution only. Distributed worldwide.
Code Information
All lots. OUS distribution only; Product is not cleared or distributed in the USA.