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.
Reported: April 17, 2013 Initiated: February 22, 2013 #Z-1076-2013
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Units Affected
- 40,819 kit and syringe units
- Distribution
- 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.
- Location
- Orange, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical. Units affected: 40,819 kit and syringe units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2013. Severity: Moderate. Recall number: Z-1076-2013.
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