FDA Device recall Z-1083-2016
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment by Ormco Sybronendo, citing 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 S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1083-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-08 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ormco Sybronendo |
| Distribution | US |
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.
Identifiers
| code_info | GE15011637 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1083-2016%22
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