Straumann TLX/TLC SP Guided Implant Driver Recall: Missing Depth Markings
Straumann recalls TLX/TLC SP Guided Implant Drivers with missing laser depth markings. This could affect dental procedures. Contact for details.
Lower-risk recall
The devices are missing the laser marked depth markings.
Contact the company
What happened, in plain English
Straumann is recalling TLX/TLC SP Guided Implant Drivers that lack laser-marked depth markings. This could lead to incorrect dental implant placement if used without the markings. Read more at govinfonow.com/recall/52654-straumann-tlx-tlc-sp-guided-implant-driver-recall-missing-depth.
Source Summary by GovInfoNow · govinfonow.com/recall/52654-straumann-tlx-tlc-sp-guided-implant-driver-recall-missing-depth · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1561-2025
Cite this page
“Straumann TLX/TLC SP Guided Implant Driver Recall: Missing Depth Markings.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52654-straumann-tlx-tlc-sp-guided-implant-driver-recall-missing-depth. Based on FDA recall #Z-1561-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1561-2025%22&limit=1).
Why it’s dangerous
The devices are missing laser marked depth markings. Without these markings, dental professionals may place implants at incorrect depths during procedures. This could lead to complications like improper healing or damage to surrounding structures.
Who’s affected
Dental professionals using the recalled TLX/TLC SP Guided Implant Drivers. Patients undergoing dental implant procedures are at risk if the driver is used without proper depth markings.
How to tell if you have this one
Check for the model name 'TLX/TLC SP Guided Implant Driver' and the reference number '037.3002'. The packaging lot number starts with LGMZ8 or GLKJ9, and the part lot number is HTXT5.
- Brand
Straumann- Category
Medical device
What to do — step by step
Check Product Details
Verify the model name, reference number, and lot numbers as described in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Indiana, Maine, Minnesota.
Recall timeline
FDA published this recall 46 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1561-2025 (March 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1561-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.