Lower riskMedical device recall · FDA · Published April 14, 2025
Straumann Plus Initial Drill Recall: Missing Laser Engraving
Straumann recalls Plus Initial Drill (Article 103.170) due to missing laser engraving of 7 mm. Affected units have specific identifiers; contact for remedy.
“Straumann Plus Initial Drill Recall: Missing Laser Engraving.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52457-straumann-plus-initial-drill-recall-missing-laser-engraving. Based on FDA recall #Z-1861-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1861-2025%22&limit=1).
The FDA announced on April 14, 2025, that Straumann USA LLC is recalling Plus Initial Drill, Article Number 103.170, because the batch was produced without the required laser engraving of 7 mm. This Class II recall involves 288 units distributed worldwide.
How to tell if you have it
Brand: Straumann
Product: Plus Initial Drill
Article Number: 103.170
Lot Number: LNWT8
The hazard
The recalled devices were manufactured without the laser engraving of 7 mm, according to the FDA.
Context
GovInfoNow's records show Straumann USA LLC has had 13 other recalls since May 27, 2021. Other recent recalls of similar products include Orthalign Drill Plate Recall: Bone Cut Risk from Manufacturing Defect (February 10, 2026) and Orthalign Drill Plate Recall: Risk of Bone Cut in Normal Use (February 10, 2026).
How to tell if you have this one
Check for Article Number 103.170 on the drill. Look for UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8 and Lot Number LNWT8.
Brand
Straumann
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the Article Number 103.170 and UDI-DI code (01)7898237561967(11)250204(17)400204(10)LNWT8 on the drill.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Indiana, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, South Carolina, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1861-2025 (April 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1861-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.