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MEDZAH ELBOW SPLINT, SMALL

Medzah Industries · Model MED-1002 · UDI-DI 00860010472170

IQI

510(k) clearances

456

Adverse events (2 deaths)

Recalls

519

Facilities

Description

Immobilize the elbow, without preventing arm movement. Ideal for covering and protecting arm IV sites. Constructed of nylon laminated foam with reinforced aluminum stays. Hook-and-loop tab closures for easy application and removal. Small Size.

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.