Straumann USA LLC: Medical Device Recall in 2025 - (Recall #: Z-1561-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 8, 2025

Date Posted: April 23, 2025

Recall Number: Z-1561-2025

Event ID: 96516

Reason for Recall:

The devices are missing the laser marked depth markings.

Status: Ongoing

Product Quantity: 45 units

Code Information:

REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated