Z-1561-2025 Class II Ongoing
FDA device recall Z-1561-2025 was initiated by Straumann USA LLC on March 8, 2025 and is designated Class II. Reason for recall: The devices are missing the laser marked depth markings. The recall status is ongoing. Affected quantity: 45 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 units
Product Description
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Reason for Recall
The devices are missing the laser marked depth markings.
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.
Code Information
REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.