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GRILLO ADAPTIVE SEATING

ORMESA SRL · Model GRILLO ADAPTIVE SEATING ROSA mis. SMALL con 863 poggiatesta posturale · UDI-DI 08055715708200

INM

510(k) clearances

3,241

Adverse events (13 deaths)

Recalls

189

Facilities

Description

GRILLO ADAPTIVE SEATING is an adjustable configuration seating system intended for children and young people with disabilities who need special supports, supports and adjustments in carrying out daily, educational and recreational activities, easily adaptable thanks to its modularity. It allows the person with disabilities of varying complexity to be positioned in the most appropriate and functional posture for the different contexts of daily life. Indicated for users who have little or no control of the trunk and head and who need adequate stabilization at the pelvic level to be able to assume, in situations where residual functionality allows it, the most appropriate posture in the various contexts.

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.