Z-2107-2025Class II

Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

Name: Z-2107-2025 Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Creator: Preat Corp
Published: 2025-06-24
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2025-06-24 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only on 2025-06-24. FDA classified it as Class II and gives the reason as "Due to manufacturing error, digital analog rotational feature is 180 degrees off". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2107-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-24
Posted: 2025-07-10
Recalling firm: PREAT Corporation
Product: Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 44 units
Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Product codes and lots: Lots: 278735, & 278402/UDI:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2107-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10

Product code NHA

K220823Class IIPreat AbutmentsPreat Corporation / cleared 2022-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)