Device product
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Z-1321-2024
Product summary
- Firm
- Preat Corp
- Event
- Event 94032
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 561 units
- Official record key
device-enforcement:Z-1321-2024
Official wording
Reason: 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.
Code information: Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489
Distribution pattern: U.S. Nationwide distribution in the states of AZ, OH and PA.
Derived failure modes
-
Unknown
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.