Prosthetic Knee Firmware Defect Risks Unintended Shutdown and Patient Falls
The RKNXC0005 RHEO KNEE XC prosthetic knee may experience firmware issues causing unintended warnings and device shutdown, creating a fall risk for patients.
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 a risk-of-harm medical device with FDA Class II classification where injury has not yet been reported. The firmware defect creates potential for device shutdown and patient falls, but no illnesses or injuries are mentioned in the source, qualifying it as Score 3 per the rubric.
Plain-English summary
The RKNXC0005 RHEO KNEE XC prosthetic knee, manufactured by Ossur H / F, is being recalled due to a firmware defect in the device.
The firmware issue can cause unintended warning alerts or unexpected device shutdown. An unexpected shutdown may cause patients to lose stability and fall.
This recall affects patients nationwide who received this prosthetic knee component. It was distributed across multiple states throughout the United States.
Patients using this prosthetic knee should contact their prosthetist or the manufacturer immediately regarding this recall.
The recalled product
- Product
- RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
- Manufacturer
- Ossur H / F
- Category
- Medical Device — Prosthetic Limb
- Affected units
- 1
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: 05690977467811/ Serial Number: HF363264
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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