FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2318-2024
·
Reported July 17, 2024
Enforcement
- Recall Number
- Z-2318-2024
- Event ID
- 94693
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Preat Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2024
- Initiation Date
- April 10, 2024
- Classification Date
- July 8, 2024
- Address
- 2625 Skyway Dr Ste B, N/A, Santa Maria, CA, 93455-1405, United States
Description
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.
Reason
Due to incorrect milled titanium abutment being packaged and labeled.
Code Info
Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Distribution
U.S.: CA, MO, and NV. O.U.S.: None
Quantity
7 abutmens