# FDA recall Z-1561-2025

> **Straumann USA LLC** · Class II · device recall initiated 2025-03-08.

## Product

TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;

## Reason for recall

The devices are missing the laser marked depth markings.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, United Kingdom.

## Key facts

- **Recall number:** Z-1561-2025
- **Recalling firm:** Straumann USA LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-08
- **Report date:** 2025-04-23

- **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-1561-2025

## Citation

> AI Analytics. FDA recall Z-1561-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1561-2025. Source: US FDA. Licensed CC0.

---

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