Z-0958-2017Class II

Straumann Twist Drill PRO 4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255...

Name: Z-0958-2017 Straumann Twist Drill PRO 4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255...
Creator: Straumann Manufacturing, Inc.
Published: 2016-11-23
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2016-11-23 / Terminated

FDA source

Straumann Manufacturing, Inc. began a recall of 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... on 2016-11-23. FDA classified it as Class II and gives the reason as "Drills cannot be inserted into handpiece due to tolerance specification not met". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0958-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-23
Posted: 2017-01-06
Terminated: 2019-08-29
Recalling firm: Straumann USA, LLC
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
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Drills cannot be inserted into handpiece due to tolerance specification not met
FDA root cause: Under Investigation by firm
Action: Straumann sent an Urgent Field Safety Notice to all affected customers via UPS on November 23, 2016 for next day delivery. Customers were requested to check inventory for the listed article and lot numbers and return all unused, packaged parts. Replacement drills will be sent upon receipt. Complete the Confirmation Form and fax the form to the number listed on the form. For questions regarding this recall call 800-448-8168.
Quantity in commerce: 120 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: LV455

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0957-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06
Z-0958-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)