PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/p...
FDA Device Recall #Z-0495-2015 — Class II — November 3, 2014
Recall Summary
| Recall Number | Z-0495-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 3, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer CAS |
| Location | Montreal, N/A |
| Product Type | Devices |
| Quantity | 15 |
Product Description
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
Reason for Recall
Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.
Distribution Pattern
US Distribution in states of: AZ, CO, IL, OR, and WA.
Lot / Code Information
BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01; Expiration dates 5/8/14-12/31/15
Other Recalls from Zimmer CAS
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1701-2015 | Class II | Tibial Alignment Guide; Orthopedic Stereotaxic ... | Apr 19, 2015 |
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.