Voco GmbH: Medical Device Recall in 2019 - (Recall #: Z-0028-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 9, 2019

Date Posted: October 9, 2019

Recall Number: Z-0028-2020

Event ID: 83385

Reason for Recall:

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

Status: Terminated

Product Quantity: 5 units

Code Information:

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

Distribution Pattern:

Distributed in the US to Iowa and New York

Voluntary or Mandated:

Voluntary: Firm initiated