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

Recall date

March 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1561-2025

FDA classification

Class II

Brand / firm

Straumann USA LLC

Sold / distributed

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.

Why it was recalled

The devices are missing the laser marked depth markings.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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