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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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