Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

TLX/TLC SP Guided Implant Driver Recalled by Straumann USA LLC Due to The devices are missing the laser marked depth...

Date: March 8, 2025
Company: Straumann USA LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Straumann USA LLC directly.

Affected Products

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

Quantity: 45 units

Why Was This Recalled?

The devices are missing the laser marked depth markings.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Straumann USA LLC

Straumann USA LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report