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U.S. Department of Health and Human Services

Class 2 Device Recall Zenith Alpha SpiralZ Endovascular Leg

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  Class 2 Device Recall Zenith Alpha SpiralZ Endovascular Leg see related information
Date Initiated by Firm January 16, 2020
Date Posted January 31, 2020
Recall Status1 Terminated 3 on November 12, 2020
Recall Number Z-1355-2020
Recall Event ID 84778
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Code Information All lots. OUS distribution only; Product is not cleared or distributed in the USA.
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
800-457-4500
Manufacturer 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 2		 Labeling design
Action 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.
Quantity in Commerce 68,241
Distribution Foreign distribution only. Distributed worldwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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