Z-0028-2020Class II

Grandio SO Heavy Flow Caps, Color A3 -

Name: Z-0028-2020 Grandio SO Heavy Flow Caps, Color A3 -
Creator: Voco GmbH
Published: 2019-07-09
License: https://open.fda.gov/license/

Voco GmbH / initiated 2019-07-09 / Terminated / root cause: manufacturing process

FDA source

Voco GmbH began a recall of Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure... on 2019-07-09. FDA classified it as Class II and gives the reason as "The metal cannula are potentially too loose and may become loose when applying the filing material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0028-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-09
Posted: 2019-10-01
Terminated: 2023-04-20
Recalling firm: Voco GmbH
Product: Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: The metal cannula are potentially too loose and may become loose when applying the filing material.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: VOCO GmbH notified customers on about 07/09/2019 via email. The letter in the email informed customers that the metal cannula are partly too loose and therefore could become loose when applying the material. VOCO GmbH instructed that affected products must be returned immediately and requested that they notify customers if affected product was further distributed.
Quantity in commerce: 5 units
Distribution: Distributed in the US to Iowa and New York
Product codes and lots: Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0028-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0028-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01

Product code EBF

K102354Class IIGrandio So Heavy FlowVoco GmbH / cleared 2010-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)