TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontic...
FDA Device Recall #Z-1083-2016 — Class II — February 8, 2016
Recall Summary
| Recall Number | Z-1083-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 8, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ormco/Sybronendo |
| Location | Glendora, CA |
| Product Type | Devices |
| Quantity | 5,568 units total (2,070 units in US) |
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
Lot / Code Information
GE15011637
Other Recalls from Ormco/Sybronendo
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1257-2020 | Class II | SnapLink, Ref Part No. 438-2190, L6R SnapLink, ... | Jan 17, 2020 |
| Z-1258-2020 | Class II | SnapLink, Ref Part No. 438-2191, L6L SnapLink, ... | Jan 17, 2020 |
| Z-2286-2020 | Class II | Ormco Damon Q2 Orthodontic Metal Bracket, Part ... | Jan 14, 2020 |
| Z-0413-2018 | Class II | Elements Obturation Unit (EOU) used with respec... | Dec 27, 2017 |
| Z-2836-2016 | Class II | Sealapex Xpress, Part No. 33639 The brand na... | Aug 31, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.