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ManaEZ Ankle 06 Small

Manamed, Inc. · Model EZANKLE06S · UDI-DI 00810113682907

ITW
1
510(k) clearances
76
Adverse events
3
Recalls
461
Facilities

Description

The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion.

Recalls

DateFirmReason
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
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
2015-04-13United Surgical AssociatesThe 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.