Dental implant abutments recalled for improper screw seat manufacturing defect
Preat Corp is recalling 145 Biomet 3i dental implant abutments due to a manufacturing defect where the screw seat is positioned too high, potentially reducing screw engagement and affecting implant stability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical dental implant component with a manufacturing defect that may affect mechanical stability. While no injuries have been reported, the manufacturing defect creates a risk-of-harm scenario, meeting the rubric criterion for High severity.
Plain-English summary
Preat Corp is recalling Biomet 3i Certain-compatible 4.1 mm Milled Titanium Abutment (Model 9001767-F), a dental implant component used to support tooth restorations. A total of 145 abutments are subject to this recall.
The abutments were manufactured with the screw seat positioned too high. This defect may cause the mating screw to have a shorter engagement length into the implant, potentially affecting the stability and function of the restoration.
The affected abutments were distributed nationwide. Patients and dental professionals in Arizona, California, Georgia, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, and Washington should check their records against the provided lot numbers.
Patients who received these abutments should contact their dentist to verify whether their restoration may be affected. Dental professionals should review their inventory for the specified lot numbers and consider contacting the manufacturer regarding options for affected abutments.
The recalled product
- Product
- 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.
- Manufacturer
- Preat Corp
- Hazard
- manufacturing-defect
- implant-failure
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03