Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0836-2024 — 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)

U.S. FDA — Device Enforcement · Argentina · 2023-12-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0836-2024
Date of alert
2023-12-07
Country / jurisdiction
Argentina
Risk level
Class II
Risk type
recall
Brand
TERRAGENE S.A.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07798164679622
Reported risk: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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