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.).
FDA Recall Z-0028-2020 · Posted 2019-10-01
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Recalling FirmVoco GmbH
Recall StatusTerminated
Product CodeEBF
Date Initiated2019-07-09
Date Terminated2023-04-20
Product Quantity5 units
Reason for Recall
The metal cannula are potentially too loose and may become loose when applying the filing material.
Firm 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.
Root Cause
Process control
Distribution Pattern
Distributed in the US to Iowa and New York
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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