TLX/TLC SP Guided Implant Driver missing laser marked depth markings
Straumann USA LLC is recalling TLX/TLC SP Guided Implant Driver units because they are missing laser marked depth markings, which may affect proper surgical placement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is an FDA Class II recall of a surgical implant guidance device where a critical marking (depth markings) is missing, creating a risk of improper surgical placement. The source text does not report any injuries or illnesses, but the missing depth markings represent a risk-of-harm product defect that could affect patient outcomes during implantation.
Plain-English summary
Straumann USA LLC is recalling TLX/TLC SP Guided Implant Driver devices (REF: 037.3002) because the devices are missing the laser marked depth markings. The affected devices may not provide the intended depth guidance during surgical implantation procedures.
The recalled product was distributed worldwide, including nationwide distribution in the United States in California, Indiana, Maine, and Minnesota, as well as in Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, and the United Kingdom. A total of 45 units have been recalled.
The affected devices include units with packaging lot numbers LGMZ8 and GLKJ9, as well as units with lot number HTXT5 engraved on the part. Healthcare providers and patients who have received this device should contact Straumann USA LLC for further information and guidance regarding their specific device.
The recalled product
- Product
- TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
- Manufacturer
- Straumann USA LLC
- Affected units
- 45
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
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