Reported Jun 4, 2025 · Ongoing

Plus Initial Drill, Article Number: 103.170;

Straumann USA LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008

Is this the product you have?

  • Plus Initial Drill
  • Article Number103.170
Lot codes and dates
  • Article Number103.170
  • UDI-DI(01)7898237561967(11)250204(17)400204(10)LNWT8
  • Lot NumberLNWT8
Amount recalled
288 units ($& US, 241 OUS)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.