Z-1561-2025Class II

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

Name: Z-1561-2025 TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002
Creator: Straumann USA LLC
Published: 2025-03-08
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2025-03-08 / Open, Classified / root cause: manufacturing process

FDA source

Straumann USA LLC began a recall of TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002 on 2025-03-08. FDA classified it as Class II and gives the reason as "The devices are missing the laser marked depth markings". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1561-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-08
Posted: 2025-04-14
Recalling firm: Straumann USA, LLC
Product: TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The devices are missing the laser marked depth markings.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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, United Kingdom.
Product codes and lots: REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1561-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1561-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-14

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)