Straumann Implant Driver Units Recalled for Missing Depth Markings
Straumann USA LLC is recalling 45 units of the TLX/TLC SP Guided Implant Driver because the devices are missing laser-marked depth markings. The affected units were distributed in the US and internationally.
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: This FDA Class II recall involves a manufacturing defect affecting a surgical device with no reported adverse events, injuries, or hospitalizations. Per the severity rubric, recalls of risk-of-harm products where injury has not been reported are classified as High (score 3).
Plain-English summary
Straumann USA LLC is recalling the TLX/TLC SP Guided Implant Driver (reference number 037.3002), a stainless steel surgical instrument used in implant procedures. The recall affects 45 units that are missing laser-marked depth markings.
The affected devices were distributed in the United States (California, Indiana, Maine, and Minnesota) and internationally to Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, and the United Kingdom. Specific affected lots are identified by packaging lot numbers LGMZ8 and GLKJ9, and by part lot number HTXT5 engraved on the device itself.
Users should identify any implant drivers matching these lot numbers and discontinue use. For replacement units or further information, contact Straumann USA LLC.
The recalled product
- Product
- TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
- Manufacturer
- Straumann USA LLC
- Hazard
- missing-depth-markings
- manufacturing-defect
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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