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.

Recall Insight

This FDA Devices action (record #Z-1987-2025) was formally reported on June 25, 2025, with the manufacturer initiating the action on April 2, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Preat Corp is listed as the recalling firm, operating out of Santa Maria, CA. Federal records indicate 145 abutments units are affected.

The documented reason for this recall is: 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 data in the federal record shows the product reached: U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.