Recall Z-1083-2016 ยท EKM Gutta-Percha
Ormco/Sybronendo
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
| Date | Feb 8, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | 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 . |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.