ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAI...
FDA Device Recall #Z-2646-2017 — Class II — May 23, 2017
Recall Summary
| Recall Number | Z-2646-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 23, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Onkos Surgical, Inc. |
| Location | Parsippany, NJ |
| Product Type | Devices |
| Quantity | 4 units |
Product Description
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Reason for Recall
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Distribution Pattern
AZ, IL & KS
Lot / Code Information
LOT 1700558
Other Recalls from Onkos Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2423-2025 | Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWE... | Jul 11, 2025 |
| Z-2425-2025 | Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM... | Jul 11, 2025 |
| Z-2424-2025 | Class II | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGM... | Jul 11, 2025 |
| Z-2042-2025 | Class II | My3D Personalized Solutions Humeral Cup, Model ... | May 20, 2025 |
| Z-1857-2025 | Class II | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number:... | Sep 22, 2024 |
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.