CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report

Plus Initial Drill, Article Number recalled by Straumann USA

Straumann USA is recalling Plus Initial Drill, Article Number: 103.170, distributed nationwide in the US. The recall was initiated on 14 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesArticle Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8

Quantity recalled288 units ($& US, 241 OUS)

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-1861-2025
FDA event ID: 96798
Recalling firm: Straumann USA, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Apr 2025
FDA classified: 28 May 2025
Reported: 4 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Apr 2025	Recall initiated by company
28 May 2025	Classified by FDA	+44 days
4 Jun 2025	Published in enforcement report	+7 days

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

Reason for recall

The referred batch was produced without the laser engraving of 7 mm.

Product as listed by the FDA

Plus Initial Drill, Article Number: 103.170;

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MN, NC, NV, NY, OH, OK, SC, TX, VA, WI and the countries of Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, Ukraine.

Nationwide Arizona California Florida Georgia Illinois Indiana Minnesota North Carolina Nevada New York Ohio Oklahoma South Carolina Texas Virginia Wisconsin

Questions about this recall

Why was it recalled?

The referred batch was produced without the laser engraving of 7 mm.

Which lots are affected?

Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8

Where was it sold?

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 26 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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