Recall Z-0160-2012 ยท EKM Gutta-Percha
Ormco Corporation
Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
| Date | Nov 4, 2011 (initiated Sep 9, 2010) |
| Status | Terminated |
| 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. Pleas |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.