The Recall Desk
HighFDA (Devices)·Z-1561-2025·Announced 2025-04-23

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.

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 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
Category
Medical Device — Surgical / Implant Guidance
Hazard
  • marking-defect
  • improper-placement-risk

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.

Related recalls

Same category