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U.S. Department of Health and Human Services

Class 3 Device Recall Bond1 Primer/Adhesive

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 Class 3 Device Recall Bond1 Primer/Adhesivesee related information
Date Initiated by FirmMay 27, 2010
Date PostedMarch 02, 2012
Recall Status1 Terminated 3 on March 02, 2012
Recall NumberZ-1142-2012
Recall Event ID 61265
510(K)NumberK973388 
Product Classification Agent, tooth bonding, resin - Product Code KLE
ProductBrand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N01IAA Bond-1 Primer/Adhesive 4ml N01IAB Bond-1 Primer/Adhesive 6ml N04 Lute-it w/ Bond-1 kit N04B Lute-t w/Bond-1 Intro Kit N31B Bond-1 C&B Prim/Adhesive N33 Cement-it Universal C&B Resin. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Code Information Item # Bottle Lot # Package Lot# N01I 185597, 192338, 202233 186658, 194491, 202885 N01IAA 185597, 192372 184876, 185342, 192372 N01IAB 183352, 183845, 202233 183466, 183948, 203221 N04 191010 200816 N04B 185597 183127 N31B 184256, 197303 184464, 204774 N33 184256 180766  
FEI Number 2024312
Recalling Firm/
Manufacturer		 Kerr Corporation
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7400
Manufacturer Reason
for Recall		The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPentron Clinical sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 7, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to complete and return an enclosed Recall Return Form via fax at 1-877-677-8844. Contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
Quantity in Commerce30,276 units total
DistributionWorldwide Distribution-USA (nationwide) and the countries of Germany, Canada, Ecuador, Egypt, Hong Kong, India, Israel, Japan, Kenya, Lebanon, Morocco, Saudi Arabia, Singapore, El Salvador, Thailand, Turkey, Taiwan, UAE, Vietnam, Armenia, Austria, Belgium, Bulgaria, Byelorussia, Cyprus, Germany, Spain, Russia, Finland, England, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Romania, Sweden, and Serbia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KLE
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