Recall Z-2318-2024 ยท NHA Abutment, Implant, Dental, Endosseous
Preat Corp
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
| Date | Jul 8, 2024 (initiated Apr 10, 2024) |
| Status | Open, Classified |
| Reason | Due to incorrect milled titanium abutment being packaged and labeled. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 7 abutmens |
| Distribution | U.S.: CA, MO, and NV. O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220823 | Preat Abutments Preat Corporation, Oct 26, 2022 |