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Walker, Mechanical

FDA product code ITJ · Class 1 · Physical Medicine

1,247
Registered devices
10,673
Adverse events
27
Recalls
14
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-08-26Nova Ortho-Med IncFirm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is t
2024-08-26Nova Ortho-Med IncFirm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is t
2024-08-26Nova Ortho-Med IncFirm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is t
2024-06-14Medical Depot Inc.The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
2024-06-14Medical Depot Inc.The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
2023-09-13Breg IncDue to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
2023-06-15Invacare CorporationPremature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks
2022-01-10Compass Health Brands (Corporate Office)Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
2021-03-01James Leckey Design LtdDue to a failure of the welds, the casters detached from the rear legs of the walker.
2020-03-06R82 A/SThe plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.