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U.S. Department of Health and Human Services

Class 2 Device Recall Grandio SO

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  Class 2 Device Recall Grandio SO see related information
Date Initiated by Firm July 09, 2019
Date Posted October 01, 2019
Recall Status1 Terminated 3 on April 20, 2023
Recall Number Z-0028-2020
Recall Event ID 83385
510(K)Number K102354  
Product Classification Material, tooth shade, resin - Product Code EBF
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.).
Code Information Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
Recalling Firm/
Manufacturer		 Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven Germany
Manufacturer Reason
for Recall		 The metal cannula are potentially too loose and may become loose when applying the filing material.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 5 units
Distribution Distributed in the US to Iowa and New York
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EBF and Original Applicant = VOCO GMBH
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