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ManaMed

Manamed, Inc. · Model ManaEZ Collar 80 · UDI-DI 00810113680460

IQK

510(k) clearances

100

Adverse events (1 deaths)

Recalls

311

Facilities

Description

The brace is intended exclusively for orthotic fittings of the cervical spine and exclusively for contact with intact skin. The brace must be used in accordance with indications determined by a physician. Designed for comfort and performance Two-piece design for easy fitting and adjusting Made with vented and breathable linter 9 different adjustment settings

Recalls

Date	Firm	Reason
2024-08-20	Ossur H / F	Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peel
2021-11-09	Ossur Americas	Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
2021-06-01	Ossur Americas	Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to incr
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.