FDA Medical devices recall ·
Plus Initial Drill, Article Number: 103.170 recall
- Recall number
- Z-1861-2025
- Date
- (initiated April 14, 2025)
- Company / brand
- Straumann USA LLC
60 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 288 units ($& US, 241 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Plus Initial Drill, Article Number: 103.170;
Why was it recalled?
The referred batch was produced without the laser engraving of 7 mm.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8
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: Arizona California Florida Georgia Illinois Indiana Minnesota North Carolina Nevada New York Ohio Oklahoma South Carolina Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1861-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.