FDA recall Z-0836-2024

Product

Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)

Reason for recall

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Distribution

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.

Key facts

Status

Ongoing

Initiation date

2023-12-07

Report date

2024-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alvear, Argentina

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2024