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U.S. Department of Health and Human Services

Class 2 Device Recall Bond1 Primer/Adhesive

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 Class 2 Device Recall Bond1 Primer/Adhesivesee related information
Date Initiated by FirmAugust 24, 2009
Date PostedMarch 16, 2010
Recall Status1 Terminated 3 on February 24, 2012
Recall NumberZ-1150-2010
Recall Event ID 54490
510(K)NumberK973388 
Product Classification Resin Tooth Bonding Agent - Product Code KLE
ProductBond-1 Primer/Adhesive. 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 Lots 186620, 190582 and 190985.
FEI Number 2024312
Recalling Firm/
Manufacturer		 Sybron Dental Specialties
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7480
Manufacturer Reason
for Recall		Some of the material has been found to be gelled and therefore becomes unusable.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn "Urgent Medical Device Recall" letter and "Recall Return Form" were sent by first class mail on August 24, 2009 to consignees. The letter acknowledged the "gelling" issue of identified lots shipped between July 2009 & August 2009. Customers were requested to return any of the remaining affected lots in their inventory. Contact Customer Service by calling 1-800-551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
Quantity in Commerce1,400
DistributionWorldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
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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