Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Kne...
FDA Device Recall #Z-0165-2016 — Class II — September 16, 2015
Recall Summary
| Recall Number | Z-0165-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 16, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Encore Medical, Lp |
| Location | Austin, TX |
| Product Type | Devices |
| Quantity | 209 units |
Product Description
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
Reason for Recall
The labeling is missing the size/diameter information.
Distribution Pattern
US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
Lot / Code Information
471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008
Other Recalls from Encore Medical, Lp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1459-2026 | Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOW... | Jan 15, 2026 |
| Z-1458-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) ... | Jan 15, 2026 |
| Z-1460-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) ... | Jan 15, 2026 |
| Z-1234-2026 | Class II | EMPOWR Acetabular System: Liner, 10 degree Hood... | Jan 5, 2026 |
| Z-1233-2026 | Class II | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: ... | Jan 5, 2026 |
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.