TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Reported: March 16, 2016 Initiated: February 8, 2016 #Z-1083-2016
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.
Details
- Recalling Firm
- Ormco/Sybronendo
- Units Affected
- 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
- Location
- Glendora, CA
Frequently Asked Questions
What product was recalled? ▼
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment. Recalled by Ormco/Sybronendo. Units affected: 5,568 units total (2,070 units in US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2016. Severity: Moderate. Recall number: Z-1083-2016.
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