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[Recalled] 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) — Due to a discrep

recall fda device argentina

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductTerragene 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)
Brand / manufacturerTERRAGENE S.A.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0836-2024
Country of noticeArgentina
Risk levelClass II
Hazard typerecall
Notice date07 December 2023
EAN / barcode07798164679622

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

This Class II recall concerns device products distributed in Argentina and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from TERRAGENE S.A.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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