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Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementati
Recalled April 17, 2013 · FDA recall Z-1076-2013 · Kerr/Pentron,
Hazard
Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly. · FDA Class II
Units
40,819 kit and syringe units
Sold at
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Serbia (Republic of Serbia), Sweden, Slovenia, Turkey, Ukraine, United Arab Emirates, Congo, The Democratic Republic of the (formerly Zaire), Kazakhstan, Lebanon, Russian Federation, South Africa, Mexico, Thailand, Brazil, China, Hong Kong, Israel, India, Japan, Malaysia, Panama, Singapore, Viet Nam.
Description
Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.
Product
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
Manufacturer(s)
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →