PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: June 25, 2025 Initiated: April 2, 2025 #Z-1987-2025

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.

Details

Recalling Firm
Preat Corp
Units Affected
145 abutments
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
Location
Santa Maria, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Preat Corp. Units affected: 145 abutments.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 25, 2025. Severity: Moderate. Recall number: Z-1987-2025.