Device product
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Z-1561-2025
Product summary
- Event
- Event 96516
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45 units
- Official record key
device-enforcement:Z-1561-2025
Official wording
Reason: The devices are missing the laser marked depth markings.
Code information: REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, United Kingdom.
Derived failure modes
-
Unknown
The devices are missing the laser marked depth markings.