Preat Corp: Device Recall

Recall #Z-2107-2025 · 06/24/2025

Class II: Risk

Recall Details

Recall Number: Z-2107-2025
Classification: Class II
Product Type: Device
Recalling Firm: Preat Corp
Status: Ongoing
Date Initiated: 06/24/2025
Location: Santa Maria, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44 units

Reason for Recall

Due to manufacturing error, digital analog rotational feature is 180 degrees off.

Product Description

Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

Distribution Pattern

US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.

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 04/02/2025

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.
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 →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.