FDA Device recall Z-1861-2025
Plus Initial Drill, Article Number: 103.170
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Plus Initial Drill, Article Number: 103.170 by Straumann Usa, citing the referred batch was produced without the laser engraving of 7 mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1861-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-14 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
Plus Initial Drill, Article Number: 103.170;
Reason
The referred batch was produced without the laser engraving of 7 mm.
Identifiers
| code_info | Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8 |
|---|
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-1861-2025%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.