Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
FDA device recall Z-2107-2025 · posted 2025-07-10 · Open, Classified
Recall details
- Recalling firm
- Preat Corp
- Reason for recall
- Due to manufacturing error, digital analog rotational feature is 180 degrees off.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 44 units
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
- Date initiated
- 2025-06-24
- Date posted
- 2025-07-10
- Location
- Santa Maria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Preat Abutments (K220823) | Preat Corporation | 2022-10-26 |