[pending] TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Pending LLM rewrite. Source: FDA_DEVICE Z-1561-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The devices are missing the laser marked depth markings.
The recalled product
- Product
- TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- REF: 037.3002
- UDI-DI: 07630031750587
- Packaging Lot number: LGMZ8
- GLKJ9
- Lot number engraved on part: HTXT5.
Distribution
Distributed nationwide across the United States.
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