ManaMed
Manamed, Inc. · Model ManaEZ ROM Elite Short · UDI-DI 00810113680668
Description
The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes. -Telescoping and malleable hinge bars extendable from 16.5" - 27" (42cm - 68.5cm) -Hinge range of motion adjustment: Flexion (0° - 120°) and extension (0° - 90°) -Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly -Lightweight, latex free breathable material -Easy application, universal size with hook and buckle closure, design fits either leg
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-06-18 | Mueller Sports Medicine, Inc | Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex". |
| 2019-11-21 | DeRoyal Industries Inc | The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound |
| 2015-11-12 | Corflex | 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, |
| 2015-11-12 | Corflex | 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, |
| 2015-11-12 | Corflex | 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, |
| 2015-11-12 | Corflex | 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, |
| 2015-11-12 | Corflex | 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, |
| 2015-11-12 | Corflex | 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, |
| 2015-11-12 | Corflex | 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, |
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