Device product
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Z-1083-2016
Product summary
- Firm
- Ormco/Sybronendo
- Event
- Event 73293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,568 units total (2,070 units in US)
- Official record key
device-enforcement:Z-1083-2016
Official wording
Reason: 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.
Code information: GE15011637
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
Derived failure modes
-
Unknown
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.