Z-1083-2016 Class II Terminated
FDA device recall Z-1083-2016 was initiated by Ormco/Sybronendo on February 8, 2016 and is designated Class II. 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… The recall status is terminated (terminated August 30, 2016). Affected quantity: 5,568 units total (2,070 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2016
- Initiation Date
- February 8, 2016
- Termination Date
- August 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,568 units total (2,070 units in US)
Product Description
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
Code Information
GE15011637