Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosth...
FDA Device Recall #Z-0455-2019 — Class II — October 2, 2018
Recall Summary
| Recall Number | Z-0455-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 2, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Straumann Manufacturing, Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 21 units |
Product Description
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Reason for Recall
Laser engraved label does not match with the item in the package
Distribution Pattern
US nationwide distribution in the states of GA, TX , VA.
Lot / Code Information
Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
Other Recalls from Straumann Manufacturing, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1694-2018 | Class II | Straumann¿ Emdogain 015, USA. Enamel Matrix Der... | Mar 23, 2018 |
| Z-1698-2018 | Class II | Straumann¿ Emdogain 0.7 ml Multipack. Enamel Ma... | Mar 23, 2018 |
| Z-1695-2018 | Class II | Straumann¿ Emdogain 0.3 ml Multipack USA. Ename... | Mar 23, 2018 |
| Z-1696-2018 | Class II | Straumann¿ Emdogain 0.3 ml Multipack. Enamel Ma... | Mar 23, 2018 |
| Z-1697-2018 | Class II | Straumann¿ Emdogain 0.7 ml Multipack USA. Ename... | Mar 23, 2018 |
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.