medical Class II Updated 2020-03-04

Cook Inc. recalls Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL.

Recalled Product

Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.

Hazard / Issue

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.

Issued by

FDA

Distribution: Foreign distribution only. Distributed worldwide.
Lot/Code Info: All lots. OUS distribution only; Product is not cleared or distributed in the USA.
View official government recall

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