Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
FDA device recall Z-1355-2020 · posted 2020-01-31 · Terminated
Recall details
- Recalling firm
- Cook Inc.
- 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.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MIH
- Quantity affected
- 68,241
- Distribution
- Foreign distribution only. Distributed worldwide.
- Date initiated
- 2020-01-16
- Date posted
- 2020-01-31
- Date terminated
- 2020-11-12
- Location
- Bloomington, IN
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