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Manamed, Inc. · Model ManaEZ Boot Pediatric - Large · UDI-DI 00810113680422

ITW

510(k) clearances

Adverse events

Recalls

459

Facilities

Description

The ManaEZ Boot Pediatric is a controlled ankle motion (CAM) walking boot for children and are to be worn to help stabilize the foot and ankle after an injury or surgery. ManaEZ Boot Pediatric boots are color coded for an easy size selection. Small: Pink Medium: Yellow Large: Teal Features and Benefits: Rocker bottom to stimulate natural gait Low profile; lightweight Anatomically-shaped plastic uprights to help facilitate a secure fit for children Easy to apply and adjust with a simple strapping and liner system Fits right and left Ideal for: Treatment of stable fractures and ankle sprains, early rehabilitation of a variety of post-surgical and post-trauma indications requiring fixed control

Recalls

Date	Firm	Reason
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
2015-04-13	United Surgical Associates	The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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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.