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DYNAMICO
ORMESA SRL · Model DYNAMICO-3 OUTDOOR USE · UDI-DI 08055715700860
10
510(k) clearances
10,673
Adverse events (40 deaths)
27
Recalls
344
Facilities
Description
Walking frame intended to provide support and safety to those subjects with reduced functional capacity of maintaining the upright position and walking independently; subjects with disabilities and impaired functional residual capacity or even semi-self-sufficient elderly subjects who must be protected during walking.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-26 | Nova Ortho-Med Inc | Firm 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 the potential for the |
| 2024-08-26 | Nova Ortho-Med Inc | Firm 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 the potential for the |
| 2024-08-26 | Nova Ortho-Med Inc | Firm 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 the potential for the |
| 2024-06-14 | Medical Depot Inc. | The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury |
| 2024-06-14 | Medical Depot Inc. | The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury |
| 2023-09-13 | Breg Inc | Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels. |
| 2023-06-15 | Invacare Corporation | Premature 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 and the Rollator can |
| 2022-01-10 | Compass 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. |
| 2021-03-01 | James Leckey Design Ltd | Due to a failure of the welds, the casters detached from the rear legs of the walker. |
| 2020-03-06 | R82 A/S | The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool. |
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Get your free API keyRead the docsData 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.