Class 2 Device Recall TF Adaptive Gutta Percha Point Size SM3 50pk

• Date Initiated by Firm: February 08, 2016
• Create Date: March 08, 2016
• Recall Status: Terminated on August 30, 2016
• Recall Number: Z-1083-2016
• Recall Event ID: 73293
• Product Classification: Gutta-percha - Product Code EKM
• Product: TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
• Code Information: GE15011637
• FEI Number: 2016150
• Recalling Firm/ Manufacturer: Ormco/Sybronendo; 1332 S Lone Hill Ave; Glendora CA 91740-5339
• For Additional Information Contact: Randy Knuckles; 909-962-5600
• Manufacturer Reason for Recall: Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.
• FDA Determined Cause: Error in labeling
• Action: An Urgent Medical Device Recall letter dated February 8, 2016 was sent to all customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form to 909-962-5605 to confirm receipt of the recall notification .
• Quantity in Commerce: 5,568 units total (2,070 units in US)
• Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.