Zenith Alpha Spiral-Z Endovascular Leg (2020-01-14)
- Starting date:
- January 14, 2020
- Posting date:
- January 31, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72221
Last updated: 2020-01-31
Affected Products
Zenith Alpha Spiral-Z Endovascular Leg
Reason
This is a product notification and is for information purposes only. No devices need to be returned. Customers are being advised to follow key points in the IFU to avoid thrombus formation and/or lumen occlusion while using the Zenith Alpha¿ Spiral-Z® Endovascular Leg on patients. A copy of an updated Planning and Sizing Worksheet is also being provided to customers.
Affected products
Zenith Alpha Spiral-Z Endovascular Leg
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- ZISL-11-110
- ZISL-11-42
- ZISL-11-59
- ZISL-11-77
- ZISL-11-93
- ZISL-13-125
- ZISL-13-59
- ZISL-13-77
- ZISL-13-93
- ZISL-16-42
- ZISL-16-59
- ZISL-16-77
- ZISL-16-93
- ZISL-20-42
- ZISL-20-59
- ZISL-20-77
- ZISL-20-93
- ZISL-24-42
- ZISL-24-59
- ZISL-24-77
- ZISL-9-77
Companies
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK