FDA Device recall Z-0958-2017
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile by Straumann Manufacturing, citing drills cannot be inserted into handpiece due to tolerance specification not met.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0958-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-23 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Straumann Manufacturing |
| Distribution | US |
Product
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Reason
Drills cannot be inserted into handpiece due to tolerance specification not met
Identifiers
| code_info | Lot Number: LV455 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2017%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.