Z-1321-2024 Class II Ongoing

Recalled by Preat Corp — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
March 27, 2024
Initiation Date
February 9, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
561 units

Product Description

Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

Reason for Recall

Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, OH and PA.

Code Information

Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489