Z-1861-2025 Class II Ongoing

Recalled by Straumann USA LLC — Andover, MA

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