Straumann Twist Drill PRO ¿4 — Class II medical device recall Z-0958-2017
Terminated recall by Straumann Manufacturing, Inc., reported 2017-01-18, distributed nationwide. Drills cannot be inserted into handpiece due to tolerance specification not met
| Recall number | Z-0958-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann Manufacturing, Inc., Andover, MA, United States |
| Recall initiated | 2016-11-23 |
| Classified | 2017-01-06 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2019-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 120 units |
| Lot numbers | LV455 |
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 for recall
Drills cannot be inserted into handpiece due to tolerance specification not met
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-0958-2017. 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.