FDA-Device2016-03-16Class II
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Ormco/Sybronendo
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
Affected count
5,568 units total (2,070 units in US)
Manufactured in
1332 S Lone Hill Ave, N/A, Glendora, CA, United States
Products
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1083-2016Don't want to check this manually?
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