FDA Medical Device Recalls (openFDA)
Ossur H / F: 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.
- Recall number
- Z-1322-2015
- Recalling firm
- Ossur H / F
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-02-26
- Posted
- 2015-03-25
- Terminated
- 2015-11-20
- Reason
- 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.
- Root cause
- Employee error
- Action
- The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instructed to send the unit in for service so the Acceptance testing can be performed for the unit in accordance to their process. If you have any questions, please contact Regulatory Affairs & Quality Assurance specialist at 949-382-3741 or email: kmontes@ossur.com.
- Quantity
- 4715 units (2 units affected)
- Distribution
- Worldwide distribution: US distribution in TN and country of: Austria.
- Lot, serial or model codes
- Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISW
- Firm FEI
- 3003764610
- Firm city
- Reykjavik
- Firm state
- not on file
- Firm country
- Iceland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28