TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
This recall has been terminated (originally issued February 8, 2016).
- Company
- Ormco/Sybronendo
- Recall Initiated
- February 8, 2016
- Terminated
- August 30, 2016
- Recall Number
- Z-1083-2016
- Quantity
- 5,568 units total (2,070 units in US)
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
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
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
Lot / Code Info
GE15011637
Root Cause
Error in labeling
Action Taken
An Urgent Medical Device Recall letter dated February 8, 2016 was sent to all customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form to 909-962-5605 to confirm receipt of the recall notification .