FDA recall Z-1561-2025

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2025-03-08

Report date

2025-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2025