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 Optibond Solo Plus

  • 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 Optibond Solo Plus see related information
Date Initiated by Firm March 03, 2006
Date Posted March 28, 2006
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-0688-06
Recall Event ID 34769
510(K)Number K991808  
Product Classification Agent, Tooth Bonding, Resin - Product Code KLE
Product Tooth bonding resin. Optibond Solo Plus Dual Cure Kit, Part Number 31736, Lot Number 427793
Code Information Lot Number: 427793
Recalling Firm/
Manufacturer		 Kerr Corp
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact Wendy Urtel
949-255-8767
Manufacturer Reason
for Recall		 The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
FDA Determined
Cause 2		 Other
Action A total of one hundred thirty five (135) consignees were sent the recall communication via USPS 1st class mail and international fax/mail on March 3 and 6, 2006, respectively. There will be an additional thirty seven (37) letters to be sent to consignees in Australia and three (3) letters to be sent to consignees in New Zealand once the Australian Therapeutic Goods Administration approves of a differently formatted letter. The consignees were instructed to complete the Return Form and return any affected product in their inventory. They were also requested to recover any affected product that they may have shipped to their customers.
Quantity in Commerce 34
Distribution Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand.
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 = SYBRON DENTAL SPECIALTIES, INC.
-
-