Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.
FDA Recall Z-0074-2010 · Posted 2009-10-23
Advertisement
Recalling FirmKerr Corp
Recall StatusTerminated
Product CodeEMA
Date Initiated2009-09-09
Date Terminated2011-12-12
Product Quantity13,518 units
Reason for Recall
The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
Firm Action
Kerr Corporation issued an "Urgent Medical Device Recall" dated September 8, 2009. The letter informed customers that the product recalled was shipped to their establishment between June and July 2009 and if they have any of the affected products listed to contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement