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ManaMed
Manamed, Inc. · Model ManaEZ Ice Wrap Knee · UDI-DI 00810113680590
10
510(k) clearances
493
Adverse events
12
Recalls
453
Facilities
Description
ManaEZ Ice Wrap Knee is a quick fitting, universal, knee range of motion orthosis. This knee brace also includes an ice pack. Removable ice pack Lightweight, latex free breathable material Effortless application, universal size with hook and loop closure Designed for either left or right 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.