FDA Device Recall Z-0028-2020: Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-2020.

Recall Res Number

Z-0028-2020

Recalling Firm / Manufacturer

Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

FEI Number

3002718942

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-07-09

Date Posted

2019-10-01

Date Terminated

2023-04-20

Product Code

EBF

Event Number

83385

Product Quantity

5 units

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.

Action Details 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.

Distribution Pattern Distributed in the US to Iowa and New York

Code Information / Serial Numbers Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021

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Medical Device Recall: Z-0028-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer