Preat Corp: Device Recall

Recall Details

Recall Number

Z-1987-2025

Classification

Class II

Product Type

Device

Recalling Firm

Preat Corp

Status

Ongoing

Date Initiated

04/02/2025

Location

Santa Maria, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

145 abutments

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.

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.

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.

Other Recalls by Preat Corp

• Class II: Risk 06/25/2025
  Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
• Class II: Risk 06/24/2025
  Due to manufacturing error, digital analog rotational feature is 180 degrees off.
• Class II: Risk 06/25/2024
  Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.

View all recalls by Preat Corp →