Z-0152-2024 Class II Ongoing

Recalled by Preat Corp — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
November 1, 2023
Initiation Date
July 18, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 units

Product Description

Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Reason for Recall

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

Distribution Pattern

US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

Code Information

UDI-DI: 00842092161364/Lot # OF018356