CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report

TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel recalled

Straumann USA is recalling TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel, distributed nationwide in the US. The recall was initiated on 8 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.

Quantity recalled45 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1561-2025
FDA event ID: 96516
Recalling firm: Straumann USA, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Mar 2025
FDA classified: 14 Apr 2025
Reported: 23 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

8 Mar 2025	Recall initiated by company
14 Apr 2025	Classified by FDA	+37 days
23 Apr 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The devices are missing the laser marked depth markings.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide California Indiana Maine Minnesota

Questions about this recall

Why was it recalled?

The devices are missing the laser marked depth markings.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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