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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/Adhesive see related information
Date Initiated by Firm May 27, 2010
Date Posted March 02, 2012
Recall Status1 Terminated 3 on March 02, 2012
Recall Number Z-1142-2012
Recall Event ID 61265
510(K)Number K973388  
Product Classification Agent, tooth bonding, resin - Product Code KLE
Product Brand 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  
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
Action Pentron 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 Commerce 30,276 units total
Distribution Worldwide 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 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 = KLE and Original Applicant = JENERIC/PENTRON, INC.
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