Reported Apr 1, 2015 · Terminated
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses…
Ossur H / F
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ossur H / F · Grjothals 5 · Reykjavik · N/A
Is this the product you have?
- The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
- Lot codes and dates
- Rheo 2 Item NumberRKN120007 Serial #s
- affected323056 321498
- Amount recalled
- 4715 units (2 units affected)
Where it was sold
Why it was recalled
The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
This product could cause temporary or reversible health problems — stop using it.
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