Straumann USA LLC: Device Recall
Recall #Z-1861-2025 · 04/14/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1861-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Straumann USA LLC
- Status
- Ongoing
- Date Initiated
- 04/14/2025
- Location
- Andover, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288 units ($& US, 241 OUS)
Reason for Recall
The referred batch was produced without the laser engraving of 7 mm.
Product Description
Plus Initial Drill, Article Number: 103.170;
Distribution Pattern
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.
Other Recalls by Straumann USA LLC
- Class II: Risk 10/17/2025
- Class II: Risk 05/01/2025
- Class II: Risk 05/01/2025
- Class II: Risk 04/17/2025
- Class II: Risk 03/08/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.