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Health·P Space·Evidence-backed problem·Published 2026-07-12

Ossur H F Grjothals 5 Reykjavik Iceland recalls an AI-enabled medical device

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 t… Recall 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.

TRV-2026-0042Official statisticsPermanent record — cite & verify
Ossur H F Grjothals 5 Reykjavik Iceland recalls an AI-enabled medical device

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The quick read

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 t… Recall 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.

Main points
  • Recalling firm: Ossur H F Grjothals 5 Reykjavik Iceland.
  • FDA’s stated 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.
  • Corrective 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 instruct…
Problem

FDA recall data identifies an AI-enabled medical device removed or corrected because 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.

The rundown

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.

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. 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 fo…

Sources

The debate