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Zenith A.T.E. Proximal and Distal Components (2017-03-22)
- Starting date:
- March 22, 2017
- Posting date:
- April 13, 2017
- 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-63002
Affected Products
- Zenith A.T.E. Proximal Component
- Zenith A.T.E. Proximal Tapered Component
- Zenith A.T.E. Distal Component
Reason
A new IFU has been approved with updated information. The updates to the IFU are of key importance when using the device to treat blunt thoracic aortic injury (BTAI), which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. This safety communication is for informational purposes only and no devices need to be returned.
Affected products
A. Zenith A.T.E. Proximal Component
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- ZTA-P-18-105
- ZTA-P-18-127
- ZTA-P-20-105
- ZTA-P-20-127
- ZTA-P-22-105
- ZTA-P-24-105
- ZTA-P-26-105
- ZTA-P-28-109
- ZTA-P-28-155
- ZTA-P-28-201
- ZTA-P-30-109
- ZTA-P-30-132
- ZTA-P-30-155
- ZTA-P-30-201
- ZTA-P-32-109
- ZTA-P-32-155
- ZTA-P-32-201
- ZTA-P-34-113
- ZTA-P-34-161
- ZTA-P-34-209
- ZTA-P-36-113
- ZTA-P-36-161
- ZTA-P-36-209
- ZTA-P-38-117
- ZTA-P-38-167
- ZTA-P-38-217
- ZTA-P-40-117
- ZTA-P-40-167
- ZTA-P-40-217
- ZTA-P-42-121
- ZTA-P-42-173
- ZTA-P-42-225
- ZTA-P-44-125
- ZTA-P-44-179
- ZTA-P-44-233
- ZTA-P-46-125
- ZTA-P-46-179
- ZTA-P-46-233
Companies
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK
B. Zenith A.T.E. Proximal Tapered Component
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- ZTA-PT-23-28-201
- ZTA-PT-32-28-178
- ZTA-PT-34-30-161
- ZTA-PT-34-30-209
- ZTA-PT-36-32-161
- ZTA-PT-36-32-209
- ZTA-PT-38-34-167
- ZTA-PT-38-34-217
- ZTA-PT-40-36-167
- ZTA-PT-40-36-217
- ZTA-PT-42-38-173
- ZTA-PT-42-38-225
- ZTA-PT-44-40-179
- ZTA-PT-44-40-233
- ZTA-PT-46-42-179
- ZTA-PT-46-42-233
Companies
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK
C. Zenith A.T.E. Distal Component
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- ZTA-D-30-160
- ZTA-D-32-160
- ZTA-PT-42-38-225
- ZTA-PT-44-40-179
- ZTA-PT-44-40-233
- ZTA-PT-46-42-179
- ZTA-PT-46-42-233
- ZTA-D-30-160
- ZTA-D-32-160
- ZTA-D-34-190
- ZTA-D-36-190
- ZTA-D-38-197
- ZTA-D-40-147
- ZTA-D-40-197
- ZTA-D-42-204
- ZTA-D-44-211
- ZTA-DE-38-91
- ZTA-DE-42-94
Companies
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK