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Terminated

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.

FDA Recall Z-1142-2012 · Posted 2012-03-02

Recalling FirmKerr Corporation
Recall StatusTerminated
Product CodeKLE
Date Initiated2010-05-27
Date Terminated2012-03-02
Product Quantity30,276 units total

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973388DENTIN CONDITIONING AND ADHESIVE (BOND 1)Jeneric/Pentron, Inc. · 1997-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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