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

FDA device recall Z-1561-2025 · posted 2025-04-14 · Open, Classified

Recall details

Recalling firm

Straumann USA LLC

Reason for recall

The devices are missing the laser marked depth markings.

Action taken

On March 8, 2024 URGENT FIELD SAFETY ACTION letters were sent to customers. Action to be taken: 1. If Article 037.3002 from Lots LGMZ8 and GLKJ9 is still in your inventory, then stop use/distribution of the product immediately and quarantine/segregate physically. 2. If Article 037.3002 from Lots LGMZ8 and GLKJ9 is still in your inventory, return it for a replacement as indicated on the Customer Confirmation Form 3. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The FDA has been informed about this Field Safety Corrective Action We apologize for any inconvenience that this may cause.

Root cause

Process control

Status

Open, Classified

Product code

NDP

Quantity affected

45 units

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, Uni

Date initiated

2025-03-08

Date posted

2025-04-14

Location

Andover, MA