Preat REF 9007121 — Class II medical device recall Z-0152-2024
Ongoing recall by Preat Corp, reported 2023-11-01, distributed in CA, FL, NJ, OH, OR, SC, TX. The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and
| Recall number | Z-0152-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preat Corp, Santa Maria, CA, United States |
| Recall initiated | 2023-07-18 |
| Classified | 2023-10-23 |
| Reported by FDA | 2023-11-01 |
| Distributed | CA, FL, NJ, OH, OR, SC, TX |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 00842092161364 |
| Lot numbers | OF018356 |
| Model numbers | 9007121 |
Product
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Reason for recall
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
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-0152-2024. 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.