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ManaEZ 3 Panel Knee Immobilizer 20"

Manamed, Inc. · Model EZ3PIMM01-20 · UDI-DI 00810113683003

IQI

510(k) clearances

456

Adverse events (2 deaths)

Recalls

519

Facilities

Description

The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The combination of the posterior stay and two adjustable lateral stays maintains the optimum leg position. The popliteal pad ensures an intimate fit around the knee joint. Available in 18", 20", and 22" lengths in our single and three-panel design. Ideal for strains and sprains of the knee, stable fractures of the tibia, and patellar tendon repairs.

Recalls

Date	Firm	Reason
2023-09-23	Townsend Design	Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
2023-09-23	Townsend Design	Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
2023-09-23	Townsend Design	Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
2018-01-31	3M Company - Health Care Business	3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur
2018-01-31	3M Company - Health Care Business	3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natur
2016-11-07	DeRoyal Industries Inc	DeRoyal received complaints of mold on Tennis Elbow Straps.
2016-11-07	DeRoyal Industries Inc	DeRoyal received complaints of mold on Tennis Elbow Straps.
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
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
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

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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.