Date Initiated by Firm |
August 29, 2006 |
Date Posted |
September 23, 2006 |
Recall Status1 |
Terminated 3 on August 03, 2012 |
Recall Number |
Z-1521-06 |
Recall Event ID |
36200 |
510(K)Number |
K014027 K991808
|
Product Classification |
Tooth bonding adhesive - Product Code KLE
|
Product |
OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966 |
Code Information |
Lot numbers: 448798, 449556 and 451706 |
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 |
Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.
|
FDA Determined Cause 2 |
Other |
Action |
A total of thirty-four (34) consignees were sent the recall communication via USPS 1st class mail on August 29, 2006. There will be an additional five (5) letters that will be sent to consignees in Europe once the recall communication is translated into their respective languages. 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. Periodic effectiveness checks will be conducted in order to follow up with non-responders. |
Quantity in Commerce |
247 Kits (50 unidose pouches/Kit) |
Distribution |
World wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom |
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 = KERR DENTAL MATERIALS CENTER 510(K)s with Product Code = KLE and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
|