TLX/TLC Implant Driver (Straumann) – depth marking missing (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Brand
Straumann USA LLC
Lot Codes / Batch Numbers
REF: 037.3002, UDI-DI: 07630031750587, Packaging Lot number: LGMZ8, GLKJ9, Lot number engraved on part: HTXT5.
Products Sold
REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
Straumann USA LLC is recalling TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; due to The devices are missing the laser marked depth markings.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices are missing the laser marked depth markings.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026