NobelBiocare Tri-Lobe-compatible WP X 6 — Class II medical device recall Z-2514-2025
Ongoing recall by Preat Corp, reported 2025-09-10, distributed nationwide. Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relatio
| Recall number | Z-2514-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preat Corp, Santa Maria, CA, United States |
| Recall initiated | 2025-06-25 |
| Classified | 2025-09-03 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| UPC / GTIN / UDI-DI | 00842092169599 |
| Lot numbers | 277097 |
| Model numbers | 9000662 |
Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Reason for recall
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
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-2514-2025. 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.