9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunctio...
FDA Device Recall #Z-2318-2024 — Class II — April 10, 2024
Recall Summary
| Recall Number | Z-2318-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 10, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Preat Corp |
| Location | Santa Maria, CA |
| Product Type | Devices |
| Quantity | 7 abutmens |
Product 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 for Recall
Due to incorrect milled titanium abutment being packaged and labeled.
Distribution Pattern
U.S.: CA, MO, and NV. O.U.S.: None
Lot / Code Information
Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Other Recalls from Preat Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2514-2025 | Class II | NobelBiocare Tri-Lobe-compatible WP X 6.0mm Eng... | Jun 25, 2025 |
| Z-2107-2025 | Class II | Preat, Astra EV-compatible 4.2mm Digital Analog... | Jun 24, 2025 |
| Z-1987-2025 | Class II | Biomet 3i Certain-compatible 4.1 mm Milled Ti A... | Apr 2, 2025 |
| Z-2687-2024 | Class II | Multiple Digital Analog Products labeled as: N... | Jun 25, 2024 |
| Z-1321-2024 | Class II | Preat Nobel Active/Conical-compatible RP Titan... | Feb 9, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.