Premier Solo Diamond — Class II medical device recall Z-1408-2025
Ongoing recall by Premier Dental Products Co, reported 2025-04-02, distributed nationwide. The hardness not meeting the material specification and may cause the diamond bur to bend.
| Recall number | Z-1408-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Premier Dental Products Co, Plymouth Meeting, PA, United States |
| Recall initiated | 2025-02-27 |
| Classified | 2025-03-21 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 77 units |
| Lot numbers | M0117646, M0120260, M0123294 |
Product
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Reason for recall
The hardness not meeting the material specification and may cause the diamond bur to bend.
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-1408-2025. 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.