FDA Medical Device Recalls (openFDA)
Ormco Corporation: Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
- Recall number
- Z-0160-2012
- Recalling firm
- Ormco Corporation
- Product
- Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
- Status
- Terminated
- Initiated
- 2010-09-09
- Posted
- 2011-11-04
- Terminated
- 2011-11-21
- Reason
- The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 111507, 082307
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EKM
- Firm FEI
- 2016150
- Firm city
- Glendora
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28