Class II

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

Straumann USA LLC · March 8, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

45 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1561-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.