U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Gutta-percha - Product Code EKM
원인
The recall was initiated because sybronendo has confirmed that the microseal master cones has been mislabeled.
조치
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.
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.
제품 설명
Microseal Master Cone Part Number: 815-9033 || Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.