Preat Implant Prosthetics recallZ-1285-2023 · Preat Corp · initiated Feb 21, 2023
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 contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
FDA root cause category: Process design
What the company is doing
On 2/21/23, recall notices were mailed to customers who were asked to discard or return affected devices to the recalling firm. In addition, in the event affected product was further distributed, customers were asked to inform their customers, or to provide a customer list so the recalling firm could notify these additional customers. The customer service number was provided: 800-232-7732
Recall details
- Recall number
- Z-1285-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 21, 2023
- Posted by the FDA
- Mar 24, 2023
- Recalling firm
- Preat Corp
- Quantity
- 26
- Product code
- NHA
- FDA submissions
- K220823
- Distribution
- US Nationwide distribution in the states of TX, OR, UT, NY.
Product description
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Code information (models, lots, serial numbers)
UDI: 00842092161326, Lots: 211891 and 211912
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Preat Implant Prosthetics 9007162Preat Corporation · Abutment, Implant, Dental, Endosseous1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K220823 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Preat Implant Prosthetics 9006767Preat Corporation · Dental Abutment Design Software For Dental Laboratory1 recall0 reports
- Preat Implant Prosthetics 9007121Preat Corporation · Abutment, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9007123Preat Corporation · Abutment, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9007124Preat Corporation · Abutment, Implant, Dental, Endosseous1 recall0 reports
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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