Recall Z-2107-2025 ยท NHA Abutment, Implant, Dental, Endosseous
Preat Corp
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
| Date | Jul 10, 2025 (initiated Jun 24, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing error, digital analog rotational feature is 180 degrees off. |
| 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 |
| Quantity | 44 units |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220823 | Preat Abutments Preat Corporation, Oct 26, 2022 |