Z-0955-2017Class II

VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use...

Name: Z-0955-2017 VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use...
Creator: Voco GmbH
Published: 2016-11-03
License: https://open.fda.gov/license/

Voco GmbH / initiated 2016-11-03 / Terminated / root cause: labeling and UDI

FDA source

Voco GmbH began a recall of 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... on 2016-11-03. FDA classified it as Class II and gives the reason as "Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0955-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-03
Posted: 2017-01-06
Terminated: 2017-08-23
Recalling firm: Voco GmbH
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.
Product code: KLE Agent, Tooth Bonding, Resin
Reason for recall: Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: REF #1515, Lot no. 1636479

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0955-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0955-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06

Product code KLE

K141610Class IIFuturabond M+Voco GmbH / cleared 2014-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)