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HomeDarco (Europe) GmbH › MECRON Knee Flexion L:600mm, OS:450mm, US:220mm

MECRON Knee Flexion L:600mm, OS:450mm, US:220mm

Darco (Europe) GmbH · Model OH600102 · UDI-DI 00609271950436

ITQ
10
510(k) clearances
489
Adverse events
12
Recalls
454
Facilities

Description

S Blue

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.