Zenith Alpha Spiral-Z Endovascular Leg recall
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Why was Zenith Alpha Spiral-Z Endovascular Leg recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots. OUS distribution only; Product is not cleared or distributed in the USA.
- Product
- Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
- Recalling firm
- Cook Inc.
- Quantity
- 68,241
- Distribution
- Foreign distribution only. Distributed worldwide.
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)