BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace ...
FDA Device Recall #Z-0578-2016 — Class II — November 12, 2015
Recall Summary
| Recall Number | Z-0578-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 12, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Corflex |
| Location | Manchester, NH |
| Product Type | Devices |
| Quantity | 10 units |
Product Description
BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.
Reason for Recall
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
Lot / Code Information
(1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015
Other Recalls from Corflex
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0580-2016 | Class II | CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: ... | Nov 12, 2015 |
| Z-0574-2016 | Class II | Corflex Contender Post-Op Knee Brace Lite Mode... | Nov 12, 2015 |
| Z-0579-2016 | Class II | ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Mo... | Nov 12, 2015 |
| Z-0575-2016 | Class II | CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Mo... | Nov 12, 2015 |
| Z-0576-2016 | Class II | HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Mode... | Nov 12, 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.