Device product
Plus Initial Drill, Article Number: 103.170;
Z-1861-2025
Product summary
- Event
- Event 96798
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 288 units ($& US, 241 OUS)
- Official record key
device-enforcement:Z-1861-2025
Official wording
Reason: The referred batch was produced without the laser engraving of 7 mm.
Code information: Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8
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.
Derived failure modes
-
Unknown
The referred batch was produced without the laser engraving of 7 mm.