NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging… recallZ-2514-2025 · Preat Corp · initiated Jun 25, 2025
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
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
FDA root cause category: Process control
What the company is doing
On 06/25/2025, recall notices were mailed to customers who were asked to do the following: 1) Stop/cease use of the product in the scope of this recall 2) This product shall be discarded or returned to the recalling firm 2) All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be notified be provided a copy of this notification and informed to notify their customers. 3) Complete and return the Customer Response Form via email to [email protected] If you have any questions or concerns, please call/email the firm at: (800) 232-7732, [email protected]
Recall details
- Recall number
- Z-2514-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 25, 2025
- Posted by the FDA
- Sep 3, 2025
- Recalling firm
- Preat Corp
- Quantity
- 11
- Product code
- NHA
- FDA submissions
- K183518
- Distribution
- US Nationwide distribution in the states of NY, FL, PA, CA, OH.
Product description
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Code information (models, lots, serial numbers)
UDI-DI: 00842092169599. Lot: 277097
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Preat 9000662Preat 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 9000967Preat Corporation · Abutment, implant, dental, endosseous1 recall0 reports
- Preat 9001767Preat 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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