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

FDA device recall Z-0160-2012 · posted 2011-11-04 · Terminated

Recall details

Recalling firm

Ormco Corporation

Reason for recall

The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

EKM

Quantity affected

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, Germ

Date initiated

2010-09-09

Date posted

2011-11-04

Date terminated

2011-11-21

Location

Glendora, CA