Recall Z-0028-2020— Voco GmbH

Name: FDA recall Z-0028-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-09

Class II · Terminated

Class II FDA medical device recall by Voco GmbH, initiated 2019-07-09, terminated 2023-04-20. It names one FDA 510(k) clearance: K102354. 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.).. Reason: The metal cannula are potentially too loose and may become loose when applying the filing material..

Recalling firm: Voco GmbH
Classification: Class II
Status: Terminated
Initiated: 2019-07-09
Terminated: 2023-04-20
Firm location: Cuxhaven, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K102354 — GRANDIO SO HEAVY FLOWVoco GmbH·cleared 2010-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.