Preat, Astra EV-compatible 4.2mm Digital Analog recallZ-2107-2025 · Preat Corp · initiated Jun 24, 2025
Class II Open, Classified All recalls posted in July 2025
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 manufacturing error, digital analog rotational feature is 180 degrees off.
FDA root cause category: Employee error
What the company is doing
On June 24, 2025 Preat Corporation issued a "Urgent: Medical Device Recall" to affected consignees via certified mail. Preat asked consignees to take following actions: 1. Immediately review your inventory for product listed in the table below. 2. Customers shall stop/cease use of the product in the scope of this recall. 3. It shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. 4. All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be provided a copy of this notification and informed to notify their customers. 5. Complete and return the Customer Response Form following completion of your reconciliation activities.
Recall details
- Recall number
- Z-2107-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2025
- Posted by the FDA
- Jul 10, 2025
- Recalling firm
- Preat Corp
- Quantity
- 44 units
- Product code
- NHA
- FDA submissions
- K220823
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Product description
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Code information (models, lots, serial numbers)
Lots: 278735, & 278402/UDI:
Other devices under the same FDA submission
5 devices cleared under K220823 — the recall does not name any of them by identifier. 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 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 18, 2026. Text above is shown as published by the FDA.
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