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DMI
D-M-S HOLDINGS, INC. · Model 501-3012-2100 · UDI-DI 00041298003458
10
510(k) clearances
10,673
Adverse events (40 deaths)
27
Recalls
344
Facilities
Description
ROLLATOR W/CURVED BACK LOOP-LK
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.