FDA Enforcement
Class II
Ongoing
Plus Initial Drill, Article Number: 103.170;
Recall: Z-1861-2025
·
Reported June 4, 2025
Enforcement
- Recall Number
- Z-1861-2025
- Event ID
- 96798
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Straumann USA LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 4, 2025
- Initiation Date
- April 14, 2025
- Classification Date
- May 28, 2025
- Address
- 60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States
Description
Plus Initial Drill, Article Number: 103.170;
Reason
The referred batch was produced without the laser engraving of 7 mm.
Code Info
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.
Quantity
288 units ($& US, 241 OUS)