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U.S. Department of Health and Human Services

Class 2 Device Recall VOCO Futurabond M adhesive

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  Class 2 Device Recall VOCO Futurabond M adhesive see related information
Date Initiated by Firm November 03, 2016
Date Posted January 06, 2017
Recall Status1 Terminated 3 on August 23, 2017
Recall Number Z-0955-2017
Recall Event ID 75782
510(K)Number K141610  
Product Classification Agent, tooth bonding, resin - Product Code KLE
Product VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or Ormocer restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator): [F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups.
Code Information REF #1515, Lot no. 1636479
Recalling Firm/
Manufacturer		 Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven Germany
Manufacturer Reason
for Recall		 Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
FDA Determined
Cause 2		 Labeling mix-ups
Action Voco Gmbh notified consignees via email on/about November 3, 2016. The consignees were informed about the incorrect labeling and requested not to use this affected lot as well as to return it. They were also requested to pass this information to their customers
Quantity in Commerce 50 units
Distribution Nationwide Distribution to FL, IA, NH, PA, SC and TX
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 = KLE and Original Applicant = VOCO GMBH
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