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ManaMed
Manamed, Inc. · Model ManaEZ Ice Wrap Hip · UDI-DI 00810113680583
10
510(k) clearances
489
Adverse events
12
Recalls
454
Facilities
Description
ManaEZ Ice Wrap Hip is a quick fitting, universal, knee range of motion orthosis. This hip 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.