Bond-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.
FDA Recall Z-1150-2010 · Posted 2010-03-16
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Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeKLE
Date Initiated2009-08-24
Date Terminated2012-02-24
Product Quantity1,400
Reason for Recall
Some of the material has been found to be gelled and therefore becomes unusable.
Firm Action
An "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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
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.
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