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M-Brace Air

INDACO SRL · Model 75 M · UDI-DI 05391512280451

ITQ Prescription
10
510(k) clearances
493
Adverse events
12
Recalls
456
Facilities

Description

The Knee Brace # 75 Artemis Light MCL-LCL Instability is for both right and left knees providing optimal support and protection following muscle, joint and/or tendon injuries, LCL MCL weakness. It is constructed exclusively from breathable hypoallergenic fabrics (neoprene and latex free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in two different areas - 2 molded aluminum hinges (lateral and medial) for optimal lateral support- 2 low profile 2mm super light rods, to keep the brace in place during compression therapy. Indications ° Traumatic pathologies: light distortions, light articular laxity, bursitis, articular effusion. ° Rehab phase: passive support during rehab, light protection during sports. ° Offers compression and slight re- alignment in the presence of mild osteorthratis ° Anatomically shaped medial and lateral aluminum polycentric hinges guarantee a complete synchrony with the natural movement of the knee. ° Breathable, 100% cotton on your skin.

Recalls

DateFirmReason
2020-06-18Mueller Sports Medicine, IncNatural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
2019-11-21DeRoyal Industries IncThe Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee 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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Data 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.