Z-0160-2012

Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during...

Name: Z-0160-2012 Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during...
Creator: Ormco Corporation
Published: 2010-09-09
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2010-09-09 / Terminated / root cause: labeling and UDI

FDA source

Ormco Corporation began a recall of Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures on 2010-09-09. The reason FDA records is "The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0160-2012
Status: Terminated
Initiated: 2010-09-09
Posted: 2011-11-04
Terminated: 2011-11-21
Recalling firm: Ormco/Sybronendo
Product: Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
Product code: EKM Gutta-Percha
Reason for recall: The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Sybron Dental Specialties, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return the affected lots of product.. Products, would be replaced at no charge or credited to their account. Customers were instructed to contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement. The affected product should be returned to SybronEndo at the following address. Please label returned product "RECALLED PRODUCT Attention: Customer Returns" SybronEndo 1332 South Lone Hik Avenue Glendora, CA 91740 ADDITIONALLY, THEY KINDLY REQUEST CONSIGNEE COOPERATION IN COMPLETING AND FAXING BACK THE ENCLOSED ACKNOWLEDGEMENT/RETURN FORM. THIS FORM MUST BE COMPLETED AND RETURNED WHETHER OR NOT YOU HAVE ANY PRODUCT TO RETURN. Customers were also asked to identify and recover the affected product lots listed above that may have been shipped to their customers. For questions regarding this recall call 909-962-5600.
Quantity in commerce: 200 units
Distribution: Worldwide Distribution - USA including AR, CA, FL, PA, GA, IL, TX, WA, NY, IN, AL & MT; Internationally to Canada, CIS (Commonwealth of Independent States, Israel, United Kingdom, Sweden, France, Germany, and Italy.
Product codes and lots: Lot Numbers: 111507, 082307

Product code EKM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)