Recalls / —

—#213088

Product

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

FDA product code

NDP — Accessories, Implant, Dental, Endosseous

Device class

Class 1

Medical specialty

Dental

Affected lot / code info

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

Why it was recalled

The devices are missing the laser marked depth markings.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Straumann USA LLC

Address

60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

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.

Timeline

Recall initiated

2025-03-08

Posted by FDA

2025-04-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #213088. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.