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Recall Observatory FDA recall evidence

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

February 08, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    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.