Straumann USA LLC: Medical Device Recall in 2025 - (Recall #: Z-1861-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Plus Initial Drill, Article Number: 103.170;

Product Classification:

Class II

Date Initiated: April 14, 2025

Date Posted: June 4, 2025

Recall Number: Z-1861-2025

Event ID: 96798

Reason for Recall:

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

Status: Ongoing

Product Quantity: 288 units ($& US, 241 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated