Z-0716-2011

SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This...

Name: Z-0716-2011 SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This...
Creator: Patterson Dental Supply, Inc.
Published: 2010-10-15
License: https://open.fda.gov/license/

Patterson Dental Supply, Inc. / initiated 2010-10-15 / Terminated / root cause: manufacturing process

FDA source

Patterson Dental Supply, Inc. began a recall of 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 A1, 20 -... on 2010-10-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0716-2011
Status: Terminated
Initiated: 2010-10-15
Posted: 2010-12-17
Terminated: 2012-09-11
Recalling firm: Patterson Dental Supply, Inc.
Product: 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 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.
Product code: EBF Material, Tooth Shade, Resin
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees 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 [email protected].
Quantity in commerce: 3,204 packages
Distribution: Nationwide Distribution -- Including DC except VT.
Product codes and lots: 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

Product code EBF

K013647Class IIRevolution Formula 2Sybron Dental Specialties, Inc. / cleared 2002-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)