TF Adaptive Gutta Percha Point recall
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Why was TF Adaptive Gutta Percha Point recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GE15011637
- Product
- TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
- Recalling firm
- Ormco/Sybronendo
- Quantity
- 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
- Recall date
- March 16, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)