Preat Implant Prosthetics recallZ-2318-2024 · Preat Corp · initiated Apr 10, 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 incorrect milled titanium abutment being packaged and labeled.
FDA root cause category: Process control
What the company is doing
On 05/21/2024, the firm sent via direct certified mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter to customers informing them that product labeled as part number 9006767-F Astra EV 4.8mm Milled Titanium Abutment may contain instead part number 9006667 Astra EV 4.2mm Milled Titanium Abutment. The potential risk identified was, the screw seat is higher than specified in the engineering drawings and required for full thread engagement with the implant. This condition reduces the screw thread engagement with the implant. Customer are instructed to: Product in the scope of this recall shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. 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. For questions or assistance contact Jose Espino at 224-622-7191 or email [email protected]
Recall details
- Recall number
- Z-2318-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 10, 2024
- Posted by the FDA
- Jul 8, 2024
- Recalling firm
- Preat Corp
- Quantity
- 7 abutmens
- Product code
- NHA
- FDA submissions
- K220823
- Distribution
- U.S.: CA, MO, and NV. O.U.S.: None
Product description
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Code information (models, lots, serial numbers)
Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Preat Implant Prosthetics 9006767Preat Corporation · Dental Abutment Design Software For Dental Laboratory1 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 9007162Preat Corporation · Abutment, Implant, Dental, Endosseous1 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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