Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Bond1 Primer/Adhesive

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Bond1 Primer/Adhesive see related information
Date Initiated by Firm August 24, 2009
Date Posted March 16, 2010
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1150-2010
Recall Event ID 54490
510(K)Number K973388  
Product Classification Resin Tooth Bonding Agent - Product Code KLE
Product 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.
Code Information Lots 186620, 190582 and 190985.
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
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.
Quantity in Commerce 1,400
Distribution Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
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.
-
-