TF Adaptive Gutta Percha Point Size SM3 50pk — Class II medical device recall Z-1083-2016
Terminated recall by Ormco/Sybronendo, reported 2016-03-16, distributed nationwide. Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic labe
| Recall number | Z-1083-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2016-02-08 |
| Classified | 2016-03-08 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-08-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, HK, MX |
| Reason classes | labeling |
| Model numbers | 815-1541 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1083-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.