Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers
Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. Since no specific injuries or illnesses are reported in the source text, it is rated as Moderate.
Plain-English summary
Ossur Americas is recalling a wide range of medical devices, including the Extreme Custom knee brace, various Rebound walkers, back support suspenders, and infant spine immobilizers. The recall includes specific items such as the Knee Shield, Patella Cup, and Unloader Custom series.
The source text indicates the recall is occurring because of a product issue, but the specific reason is cut off in the provided text. The recall involves 7 units of the Extreme Custom product, which is used to provide support for knee instability due to ligament injuries and osteoarthritis.
The affected products were distributed across numerous U.S. states, including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, and WV. Consumers should stop using these products and contact the manufacturer for instructions.
The recalled product
- Product
- Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
- Manufacturer
- Ossur H / F
- Hazard
- Affected units
- 7
Distribution
Part of a larger recall action
This product is one of 14 recalled by Ossur H / F under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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