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Unite Medical®
Unite Medical, LLC · Model Double Upright Knee Orthosis (Left,Small) · UDI-DI 00850012035367
10
510(k) clearances
493
Adverse events
12
Recalls
454
Facilities
Description
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
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.