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U.S. Department of Health and Human Services

Class 2 Device Recall Kerr Revolution Formula 2 Flowable Light Cure Composite

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 Class 2 Device Recall Kerr Revolution Formula 2 Flowable Light Cure Compositesee related information
Date Initiated by FirmOctober 15, 2010
Date PostedDecember 17, 2010
Recall Status1 Terminated 3 on September 11, 2012
Recall NumberZ-0716-2011
Recall Event ID 57242
510(K)NumberK013647 
Product Classification Tooth Shade Resin Material - Product Code EBF
ProductSDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. Revolution is a flowable light cure hybrid resin restorative.
Code Information Shade A1 - Patterson Item # 434-4719;Kerr Part # 29493 Shade A2 - Patterson Item # 434-4727; Kerr Part # 29494 Shade A3 - Patterson Item # 434-4735; Kerr Part # 29495 Shade B1 - Patterson Item # 434-4768; Kerr Part # 29498 
Recalling Firm/
Manufacturer		 Patterson Dental Supply, Inc.
1031 Mendota Heights Rd
Saint Paul MN 55120
For Additional Information Contact
651-688-1802
Manufacturer Reason
for Recall		Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution Formula 2 (Kerr Corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by Kerr and, thus, not authentic product.
FDA Determined
Cause 2		Other
ActionConsignees were sent a Patterson Dental "Urgent Device Recall" letter dated October 15, 2010. The letter was addressed to "Valued Customer". The letter described the product and the problem. It also advised the consignees to quarantine and return the product with the specific distribution dates. Consignees were to complete and return the enclosed Recall Return Form along with the affected product. Questions should be directed to Nancy Strand at 651-686-1966 or nancy.strand@pattersondental.com.
Quantity in Commerce3,204 packages
DistributionNationwide Distribution -- Including DC except VT.
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 = EBF
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