Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308...
FDA Device Recall #Z-0174-2015 — Class II — September 24, 2014
Recall Summary
| Recall Number | Z-0174-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 24, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Straumann USA, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 111 units |
Product Description
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. 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. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
Reason for Recall
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Lot number: GY256
Other Recalls from Straumann USA, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0981-2015 | Class II | Drill set long, drill stop compatible for 4.8mm... | Oct 27, 2014 |
| Z-0117-2015 | Class II | Straumann Bone Level Tapered Implant 04.1 mm RC... | Sep 19, 2014 |
| Z-2161-2012 | Class II | Straumann Narrow CrossFit (NC) Screw for CARES ... | Jul 11, 2012 |
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.