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TROLLI

ORMESA SRL · Model TROLLI T60 MIS.40 DA AUTOSPINTA · UDI-DI 08055715707746

INM

510(k) clearances

3,241

Adverse events (13 deaths)

Recalls

189

Facilities

Description

TROLLI is a wheelchair designed to facilitate the displacement of adults and children with walking issues: subjects with pathological pictures that do not require specific postural measures and that do not have complete autonomy. It allows the positioning of the user with disabilities of varying complexity, in the most appropriate and functional posture in the different everyday environments. The postural components (supports and belts) allow to give stability to the pelvis, lower limbs and trunk. It can be used even in medium severity circumstances, in outdoor and indoor environments, for the transport of those subjects, who are not able to independently maintain the seating posture due to severe disorders of the nervous and muscle system or of the rational sphere.

Recalls

Date	Firm	Reason
2021-11-19	Ki Mobility Llc	The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
2021-07-08	Sunrise Medical (US) LLC	The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-07-08	Sunrise Medical (US) LLC	The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-06-21	Accora Inc	The firm has identified a potential for the backrest to become detached from the chair.
2019-03-28	R82 A/S	Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
2017-06-30	R82 A/S	Replacement campaign on all units that have a gas spring head in aluminum.
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when

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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.