FDA recall Z-1861-2025

Straumann USA LLC · Class II · device

Product

Plus Initial Drill, Article Number: 103.170;

Reason for recall

The referred batch was produced without the laser engraving of 7 mm.

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.

Key facts

Status
Ongoing
Initiation date
2025-04-14
Report date
2025-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1861-2025