Straumann USA LLC: TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;

Hazard

The devices are missing the laser marked depth markings.

Details from the source

Reason for recall: The devices are missing the laser marked depth markings. Distribution: 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. Quantity: 45 units Lot/code info: REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.

UPC codes

07630031750587

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.