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U.S. Department of Health and Human Services

Class 2 Device Recall Kerr Corporation OptiBond Solo Plus SelfEtch Adhesive System

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 Class 2 Device Recall Kerr Corporation OptiBond Solo Plus SelfEtch Adhesive Systemsee related information
Date Initiated by FirmAugust 29, 2006
Date PostedSeptember 23, 2006
Recall Status1 Terminated 3 on August 03, 2012
Recall NumberZ-1521-06
Recall Event ID 36200
510(K)NumberK014027 K991808 
Product Classification Tooth bonding adhesive - Product Code KLE
ProductOptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966
Code Information Lot numbers: 448798, 449556 and 451706
FEI Number 2024312
Recalling Firm/
Manufacturer		 Kerr Corp
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information ContactWendy 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
ActionA 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 Commerce247 Kits (50 unidose pouches/Kit)
DistributionWorld wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KLE
510(K)s with Product Code = KLE
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