Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments ar...
FDA Device Recall #Z-1987-2025 — Class II — April 2, 2025
Recall Summary
| Recall Number | Z-1987-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 2, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Preat Corp |
| Location | Santa Maria, CA |
| Product Type | Devices |
| Quantity | 145 abutments |
Product Description
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
Reason for Recall
Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
Lot / Code Information
Model Number: 9001767-F UDI-DI code: 00842092166093 Lot Numbers: CN932775 ED11-202416933 ED11-20249907 ED11-202435949 CN939348 ED11-202417239 ED11-202411745 ED11-202436404 CN945176 ED11-202419976 ED11-202413957 ED11-202437437 CN946712 ED11-202422121 ED11-202414696 ED11-202437710 TEC29015668 ED11-202422577 ED11-202416838 ED11-202437908 29018601 ED11-202428254 ED11-202433998 ED11-202449612 RD10511988 ED11-202428428 ED11-202435120 242070 2905742 ED11-20249819 ED11-202435909 20-607-UCHE-000603 8-663465-000743 3-16287-002239 14-493GARIEPY-000488 20-769300-000697 20-663461ROBI-000707 30-15958-002006 7-804684-001981 13-766227-000633 6-662469CARM-000576 20-15117-001341 22-790909-001273 8-489686-000448 30-Y097-002143 19-14364-001061 10-788120-001206 7-754951-000206 3-RIEHL-001837 CO19-2024-91576 CO19-2024-68877 CO19-2024-36953 CO19-2024-24127
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-2687-2024 | Class II | Multiple Digital Analog Products labeled as: N... | Jun 25, 2024 |
| Z-2318-2024 | Class II | 9006767 Astra EV 4.8mm Milled Titanium Abutment... | Apr 10, 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.