Z-1861-2025 Class II Ongoing
FDA device recall Z-1861-2025 was initiated by Straumann USA LLC on April 14, 2025 and is designated Class II. Reason for recall: The referred batch was produced without the laser engraving of 7 mm. The recall status is ongoing. Affected quantity: 288 units ($& US, 241 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- April 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288 units ($& US, 241 OUS)
Product Description
Plus Initial Drill, Article Number: 103.170;
Reason for Recall
The referred batch was produced without the laser engraving of 7 mm.
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.
Code Information
Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8