The Rheo Knee bionic prosthetic is to be used recall
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to…
Why was The Rheo Knee bionic prosthetic is to be used 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498
- Product
- The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to…
- Recalling firm
- Ossur H / F
- Quantity
- 4715 units (2 units affected)
- Distribution
- Worldwide distribution: US distribution in TN and country of: Austria.
- Recall date
- April 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)