Recall Z-1561-2025— Straumann USA LLC

Name: FDA recall Z-1561-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-08

Class II · Ongoing

Class II FDA medical device recall by Straumann USA LLC, initiated 2025-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;. Reason: The devices are missing the laser marked depth markings..

Recalling firm: Straumann USA LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-08
Firm location: Andover, MA, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.