CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
FDA Device Recall #Z-2521-2018 — Class II — June 21, 2018
Recall Summary
| Recall Number | Z-2521-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 21, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DePuy Orthopaedics, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | N/A |
Product Description
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Reason for Recall
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Distribution Pattern
Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.
Lot / Code Information
5307603 5300997
Other Recalls from DePuy Orthopaedics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1456-2024 | Class II | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee w... | Mar 12, 2024 |
| Z-1264-2023 | Class II | Attune Revision Limb Preservation System (LPS) ... | Feb 15, 2023 |
| Z-1267-2023 | Class II | Attune Posterior (PS) Fixed Bearing (FB) Tibial... | Feb 15, 2023 |
| Z-1263-2023 | Class II | Attune Revision Limb Preservation System (LPS) ... | Feb 15, 2023 |
| Z-1266-2023 | Class II | Attune Revision Limb Preservation System (LPS) ... | Feb 15, 2023 |
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.