Neodent GM X 6mm Engaging Titanium Base — Class II medical device recall Z-1285-2023
Ongoing recall by Preat Corp, reported 2023-04-05, distributed nationwide. Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base aft
| Recall number | Z-1285-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preat Corp, Santa Maria, CA, United States |
| Recall initiated | 2023-02-21 |
| Classified | 2023-03-24 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 26 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00842092161326 |
| Lot numbers | 211891, 211912 |
| Model numbers | 9007162 |
Product
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1285-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.