Prosthetic knee recalled due to firmware defect causing device shutdown
Ossur RHEO KNEE prosthetic units recalled due to firmware issues causing unintended warnings and device shutdown, which could result in patient falls.
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: This is an FDA Class II medical device recall involving a critical ambulatory prosthetic component with potential for serious patient injury (falls from unexpected device shutdown). No illnesses or injuries have been reported, placing this in the High severity category as a risk-of-harm product without documented harm.
Plain-English summary
The FDA is recalling the RKN130003 RHEO KNEE prosthetic knee with 3-year warranty, manufactured by Ossur H/F. This external lower limb prosthetic component is subject to recall due to firmware issues.
The prosthetic knee's firmware can cause unintended warnings and unexpected device shutdown during use. Device shutdown could result in the user falling, creating a serious injury risk.
143 units with specific serial numbers have been distributed nationwide across the United States. Users of affected prosthetic knees should immediately verify their device's serial number against the recall notice.
If your prosthetic knee's serial number is listed, contact your prosthetist or the manufacturer immediately. Do not use the device until it has been evaluated or replaced.
The recalled product
- Product
- RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Manufacturer
- Ossur H / F
- Category
- Medical Device — Prosthetic Limb
- Affected units
- 143
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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