FDAClass IIOctober 9, 2019

Grandio SO Heavy Flow Caps recall

Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended…

Why was Grandio SO Heavy Flow Caps recalled?

The metal cannula are potentially too loose and may become loose when applying the filing material.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021

Product
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended…
Recalling firm
Voco GmbH
Quantity
5 units
Distribution
Distributed in the US to Iowa and New York
Recall date
October 9, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls