Preat Nobel Active/Conical-compatible RP Titanium Blank… recallZ-1321-2024 · Preat Corp · initiated Feb 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Preat Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
On 02/09/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via US certified mail to customers to inform them that the abutment was manufactured with a dimensional condition that may lead to reduced engagement between the prosthetic screw and the implant. Customer are instructed to inspect their inventory and discard or return the affected products to PREAT CORPORATION. For questions or further assistance contact the Quality Assurance Manager at 800-232-7732 or email at [email protected] On 2/16/2024, the firm sent via certified USPS mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" which informs customer to notify all personnel within their company, and of their customers where the affected products may have been further distributed of the recall.
Recall details
- Recall number
- Z-1321-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 9, 2024
- Posted by the FDA
- Mar 20, 2024
- Recalling firm
- Preat Corp
- Quantity
- 561 units
- Product code
- NHA
- FDA submissions
- K183518
- Distribution
- U.S. Nationwide distribution in the states of AZ, OH and PA.
Product description
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Code information (models, lots, serial numbers)
Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Preat 9000967Preat Corporation · Abutment, implant, dental, endosseous1 recall0 reports
Other devices under the same FDA submission
4 devices cleared under K183518 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Preat 9001767Preat Corporation · Abutment, implant, dental, endosseous1 recall0 reports
- Preat 9000662Preat Corporation · Abutment, implant, dental, endosseous1 recall0 reports
- O-Ring 1700554Preat Corporation · Abutment, Implant, Dental, Endosseous4 reports
- O-Ring 1700552Preat Corporation · Abutment, Implant, Dental, Endosseous1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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