Ossur Recalls Multiple Medical Devices Including Miami J Collars
Ossur Americas is recalling various medical devices, including Miami J collars and knee shields, due to a manufacturing defect.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source does not report specific injuries or deaths, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ossur Americas is recalling a range of medical devices, including the Miami J Collar, Knee Shield / Patella Cup, NecLoc Extrication Collar, Rebound walkers, back support suspenders, and Papoose Infant Spine Immobilizers. The recall involves 15,825 units of the Miami J Collar specifically, distributed across numerous U.S. states and the District of Columbia.
The recall was initiated because the products are affected by a manufacturing defect. The source text indicates the defect involves the 'p' (likely a truncated word such as 'product' or 'part'), but the specific nature of the defect is not fully detailed in the provided excerpt. These devices are used for patient immobilization and support, such as for cervical injuries or knee protection.
Consumers and healthcare providers should stop using the affected devices immediately. Affected items include specific model numbers such as MJ-200B, MJ-200L, and MJ-250. Users should contact Ossur Americas for instructions on returning or replacing the products.
The recalled product
- Product
- Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
- Manufacturer
- Ossur H / F
- Hazard
- Affected units
- 15,825
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.
See all 14 products in this recall →Related recalls
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