Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article N...
FDA Device Recall #Z-0957-2017 — Class II — November 23, 2016
Recall Summary
| Recall Number | Z-0957-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 23, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Straumann Manufacturing, Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 165 units |
Product Description
Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Reason for Recall
Drills cannot be inserted into handpiece due to tolerance specification not met
Distribution Pattern
Nationwide Distribution
Lot / Code Information
Lot Number: LV463, MG783, MH027
Other Recalls from Straumann Manufacturing, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0455-2019 | Class II | Neodent¿ GM Mini Conical Abutment - Product Usa... | Oct 2, 2018 |
| 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 |
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.