CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Straumann Twist Drill PRO ¿,long,SS-Non sterile recalled

Straumann Manufacturing is recalling Straumann Twist Drill PRO ¿,long,SS-Non sterile, distributed nationwide in the US. The recall was initiated on 23 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: LV455

Quantity recalled120 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0958-2017
FDA event ID: 75983
Recalling firm: Straumann Manufacturing, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 23 Nov 2016
FDA classified: 6 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

23 Nov 2016	Recall initiated by company
6 Jan 2017	Classified by FDA	+44 days
18 Jan 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Drills cannot be inserted into handpiece due to tolerance specification not met

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Straumann Twist Drill PRO ¿,long,SS-Non sterile recalled?

Yes. Straumann Manufacturing recalled Straumann Twist Drill PRO ¿,long,SS-Non sterile on 23 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0958-2017.

Why was it recalled?

Drills cannot be inserted into handpiece due to tolerance specification not met

Which lots are affected?

Lot Number: LV455

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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