FDA Device recall Z-1408-2025
Premier Solo Diamond - Large Invented Cone
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Premier Solo Diamond - Large Invented Cone by Premier Dental Products, citing the hardness not meeting the material specification and may cause the diamond bur to bend.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1408-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-27 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Premier Dental Products |
| Distribution | US |
Product
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Reason
The hardness not meeting the material specification and may cause the diamond bur to bend.
Identifiers
| code_info | SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1408-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.