Z-1321-2024 Class II Ongoing
FDA device recall Z-1321-2024 was initiated by Preat Corp on February 9, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 561 units.
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