9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous denta
FDA device recall Z-2318-2024 · posted 2024-07-08 · Open, Classified
Recall details
- Recalling firm
- Preat Corp
- Reason for recall
- Due to incorrect milled titanium abutment being packaged and labeled.
- Action taken
- 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 jespino@younginnovations.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 7 abutmens
- Distribution
- U.S.: CA, MO, and NV. O.U.S.: None
- Date initiated
- 2024-04-10
- Date posted
- 2024-07-08
- Location
- Santa Maria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Preat Abutments (K220823) | Preat Corporation | 2022-10-26 |