Home / Recalls / Medical Devices
Straumann USA LLC recalls TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Recalled April 23, 2025 · FDA recall Z-1561-2025 · Straumann USA
Hazard
The devices are missing the laser marked depth markings. · FDA Class II
Units
45 units
Sold at
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.
Description
The devices are missing the laser marked depth markings.
Product
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Manufacturer(s)
Straumann USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →