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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall TF Adaptive Gutta Percha Point Size SM3 50pk see related information
Date Initiated by Firm February 08, 2016
Create Date March 08, 2016
Recall Status1 Terminated 3 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
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 2		 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.
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