# FDA recall Z-1861-2025

> **Straumann USA LLC** · Class II · device recall initiated 2025-04-14.

## 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

- **Recall number:** Z-1861-2025
- **Recalling firm:** Straumann USA LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-14
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1861-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1861-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*