Recall Z-1355-2020
Cook Inc. · initiated January 16, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Codes / lots: All lots. OUS distribution only; Product is not cleared or distributed in the USA.
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.
FDA-determined cause: Labeling design
Action taken
On January 14, 2020, the firm notified affected customers via Urgent Medical Device Correction letters/emails. Customers were advised to pay especial attention to several aspects of the Instructions for Use (IFU) which were of key importance when implanting a device. Customers were also provided with an updated Planning and Sizing Worksheet. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Details
- Recall number
- Z-1355-2020
- Initiated
- January 16, 2020
- Posted by FDA
- January 31, 2020
- Terminated
- November 12, 2020
- Product code
- MIH – System, Endovascular Graft, Aortic Aneurysm Treatment
- Quantity
- 68,241
- Distribution
- Foreign distribution only. Distributed worldwide.
- Recalling firm
- Cook Inc., Bloomington, IN