Device product
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Z-2318-2024
Product summary
- Firm
- Preat Corp
- Event
- Event 94693
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 abutmens
- Official record key
device-enforcement:Z-2318-2024
Official wording
Reason: Due to incorrect milled titanium abutment being packaged and labeled.
Code information: Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Distribution pattern: U.S.: CA, MO, and NV. O.U.S.: None
Derived failure modes
-
Unknown
Due to incorrect milled titanium abutment being packaged and labeled.