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U.S. Department of Health and Human Services

Class 3 Device Recall Kerr TempBond Clear

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  Class 3 Device Recall Kerr TempBond Clear see related information
Date Initiated by Firm September 09, 2009
Date Posted October 23, 2009
Recall Status1 Terminated 3 on December 12, 2011
Recall Number Z-0074-2010
Recall Event ID 53296
510(K)Number K982590  
Product Classification Cement, dental - Product Code EMA
Product 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.
Code Information Part Number 33351, Lot Numbers: 3252902, 3229807, 3268505, 3277455, 3257280, 3258772 and 3269811.
Recalling Firm/
Manufacturer		 Kerr Corp
1717 W Collins Ave
Orange CA 92867
Manufacturer Reason
for Recall		 The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 13,518 units
Distribution Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe.
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 = EMA and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
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