Reported Apr 23, 2025 · Ongoing
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Straumann USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel
- REF037.3002
- Lot codes and dates
- REF037.3002
- UDI-DI07630031750587
- Packaging Lot number
LGMZ8GLKJ9
- Lot number engraved on partHTXT5
- Amount recalled
- 45 units
Where it was sold
Why it was recalled
The devices are missing the laser marked depth markings.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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