Recall Z-1083-2016— Ormco/Sybronendo
Class II · Terminated
Class II FDA medical device recall by Ormco/Sybronendo, initiated 2016-02-08, terminated 2016-08-30. FDA's recall record names no specific 510(k) clearance for this event. Product: TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment. 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..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-08
- Terminated
- 2016-08-30
- Firm location
- Glendora, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.