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:

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