Preat Implant Prosthetics recallZ-0152-2024 · Preat Corp · initiated Jul 18, 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
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
FDA root cause category: Process change control
What the company is doing
On August 4, 2023, Preat Corporation issued a "Urgent Medical Device Recall" notification via: USPS. Preat ask consignees to take the following actions: Product within the scope of the recall shall be discarded or returned to Preat Corporation. Instructions for the return will be provided. Complete and email response form to Nichole Fetterman, E-Mail: [email protected] or mail to Preat Corporation, Attn. Nichole Fetterman, 2625 Skyway Drive, Ste. B, Santa Maria, CA 93455
Recall details
- Recall number
- Z-0152-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 18, 2023
- Posted by the FDA
- Oct 24, 2023
- Recalling firm
- Preat Corp
- Quantity
- 13 units
- Product code
- NHA
- FDA submissions
- K220823
- Distribution
- US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Product description
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Code information (models, lots, serial numbers)
UDI-DI: 00842092161364/Lot # OF018356
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Preat Implant Prosthetics 9007121Preat 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 9007162Preat 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
Other products in the same recall event
The FDA groups related products into one recall event (event 92867).
- Z-0153-2024 · Open, ClassifiedPreat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Z-0154-2024 · Open, ClassifiedPreat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
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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