Known Identifiers & Locations
FEI Numbers
3005580113
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0043-2026 |
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2-
Reference Part Numbers
ZTA2-P-40-117-W
ZTA2-P-40-167
ZTA2-P-40-167-W
ZTA2-P-40-217-W
ZTA2-P-42-121
ZTA2-P-42-121-W
ZTA2-P-42-173
ZTA2-P-42-173-W
ZTA2-P-42-225
ZTA2-P-42-225-W
ZTA2-P-44-125
ZTA2-P-44-125-W
ZTA2-P-44-179
ZTA2-P-44-179-W
ZTA2-P-44-233
ZTA2-P-44-233-W
ZTA2-P-46-125
ZTA2-P-46-125-W
ZTA2-P-46-179
ZTA2-P-46-179-W
ZTA2-P-46-233-W
ZTA2-PT-40-36-167
ZTA2-PT-40-36-167-W
ZTA2-PT-40-36-217
ZTA2-PT-40-36-217-W
ZTA2-PT-42-38-173
ZTA2-PT-42-38-173-W
ZTA2-PT-42-38-225
ZTA2-PT-42-38-225-W
ZTA2-PT-44-40-179
ZTA2-PT-44-40-179-W
ZTA2-PT-44-40-233-W
ZTA2-PT-46-42-179
ZTA2-PT-46-42-179-W
ZTA2-PT-46-42-233
ZTA2-PT-46-42-233-W
ZTA2-P-46-233
ZTA2-PT-44-40-233
ZTA2-P-40-217
ZTA2-P-40-117
ZTA2-P-40-167-DEMO
ZTA2-P-44-152-W
ZTA2-P-40-142
ZTA2-P-44-152
ZTA2-P-40-142-W
Reason: Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
|
2025-09-18 |
Open, Classified
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.