Class 2 Device Recall PREMISE

• Date Initiated by Firm: September 05, 2008
• Date Posted: November 25, 2008
• Recall Status: Terminated on March 07, 2012
• Recall Number: Z-0232-2009
• Recall Event ID: 49506
• 510(K)Number: K060472
• Product Classification: dental composite - Product Code EBF
• Product: PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental composite
• Code Information: LOT NUMBER(S): 3001279, 3001280, 3027784, 3031663, and 3045735.
• Recalling Firm/ Manufacturer: Kerr Corp; 1717 W Collins Ave; Orange CA 92867-5422
• Manufacturer Reason for Recall: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
• FDA Determined Cause: Component design/selection
• Action: Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739. If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers. Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement
• Quantity in Commerce: 22,478 packs for all affected lots
• Distribution: Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
• 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 = EBF