Preat Corp Recall 91876
Description: Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Preat Corp Recall 91876 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1285-2023 |
| Event ID | 91876 |
| Event Description | Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of TX, OR, UT, NY. |
| Quantity | 26 |
| Recall Reason | Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient. |
| Device Classification | 20230405 |
| Device Code Info | UDI: 00842092161326, Lots: 211891 and 211912 |
| Center Classification Date | 20230324 |
| Recall Initiation Date | 20230221 |
| Recalling Firm | Preat Corp |
| Initial Notification | Letter |
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