DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

FDA Device Recall #Z-0706-2020 — Class II — November 21, 2019

Recall Summary

Recall Number Z-0706-2020
Classification Class II — Moderate risk
Date Initiated November 21, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DeRoyal Industries Inc
Location Powell, TN
Product Type Devices
Quantity 2789 units

Product Description

DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

Reason for Recall

The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.

Distribution Pattern

Nationwide, Australia, India, Saudi Arabia

Lot / Code Information

1) REF KB9000-01 Lot Numbers: 9798560, 49798543, 49976101, 49798578, 49976119, 50166762, 50166842, 50353058, 50353066, 50353074, 50353082, 50353091, 50353103, 50471126, 50575494, 50555223 2) REF 11-450A-00 Lot Numbers: 9798480, 50226649, 50226665, 49832318, 49976047, 50034962, 49976063, 49976071, 50167028, 50167052, 50166949, 50343909, 50353023, 50353031, 50353040, 50429112, 50465800, 50465797, 50555258, 50653675 3) REF 1150UTPP Lot Numbers: 49799386, 49843130, 49910865, 49976645, 49976637, 50166447, 50343870, 50352952, 50352961, 50352979, 50352987, 50352995, 50385594

Other Recalls from DeRoyal Industries Inc

Recall # Classification Product Date
Z-1291-2025 Class II DeRoyal REF 71-C5100NS Tubing, Suction, Connect... Jan 31, 2025
Z-1174-2025 Class II DeRoyal AMG Suction Connector Tubing REF: 71-2... Jan 15, 2025
Z-0306-2025 Class II DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 Oct 3, 2024
Z-0307-2025 Class II DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-93... Oct 3, 2024
Z-0308-2025 Class II DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-934... Oct 3, 2024

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.