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TLX/TLC SP Guided Implant Driver, for ratchet, stainless… recallZ-1561-2025 · Straumann USA LLC · initiated Mar 8, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The devices are missing the laser marked depth markings.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1561-2025
Status
Open, Classified
Initiated by the company
Mar 8, 2025
Posted by the FDA
Apr 14, 2025
Recalling firm
Straumann USA LLC
Quantity
45 units
Product code
NDP
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, United Kingdom.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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