Prosthetic knee recalled due to firmware issues causing potential device shutdown
Ossur H/F is recalling RHEO KNEE prosthetic knee components due to firmware issues that could cause unintended warnings and device shutdown, creating fall risk for users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall. While no illnesses or injuries have been reported, the firmware defect poses a significant risk of falls in prosthetic knee users due to potential unexpected device shutdown, meeting the criterion for a risk-of-harm product.
Plain-English summary
Ossur H / F is recalling the RHEO KNEE 2 YR WARRANTY (Model RKN130002), an external lower limb prosthetic component, due to firmware issues. The firmware defect can cause unintended warnings and unexpected device shutdown.
The risk posed by this defect is that device shutdown in a prosthetic knee could result in patient falls and sudden loss of mobility. While no injuries have been reported to date, the potential for serious harm exists.
The affected product has been distributed nationwide across the United States. Patients and healthcare providers should contact Ossur H / F or their prosthetics provider for information about remediation options and the recall process.
The recalled product
- Product
- RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Manufacturer
- Ossur H / F
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 05690967598426/ Serial Number: HF377253 1
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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