The Recall Desk
HighFDA (Devices)·Z-0028-2020·Announced 2019-10-09

Voco Grandio SO Heavy Flow Caps Recalled for Loose Cannula

Voco GmbH is recalling Grandio SO Heavy Flow Caps because the metal cannula may be too loose and detach during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Voco GmbH is recalling Grandio SO Heavy Flow Caps, Color A3, due to a defect in the metal cannula. The cannula is potentially too loose and may become loose when applying the filling material.

The affected product is identified by Item Number 2706, Lot Number 1923282, and an expiration date of 12/28/2021. The recall involves 5 units that were distributed in the US to Iowa and New York.

Consumers and healthcare providers should stop using the affected product and contact Voco GmbH for further instructions or a replacement.

The recalled product

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
Manufacturer
Voco GmbH
Category
Medical Device — Dental Filling Material
Hazard
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed in 2 states:

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