LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for ...
FDA Device Recall #Z-1672-2015 — Class II — March 4, 2015
Recall Summary
| Recall Number | Z-1672-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 4, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DePuy Orthopaedics, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 19,059 |
Product Description
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Reason for Recall
The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
Lot / Code Information
All Lots. Catalog numbers: 129411010 129411020 129411030 129411040 129411050 129411060 129411070 129412010 129412020 129412030 129412040 129412050 129412060 129412070 129495040 129495050 129495060 129496040 129496050 129496060
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.