PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 1, 2015 Initiated: February 26, 2015 #Z-1322-2015

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Ossur H / F
Units Affected
4715 units (2 units affected)
Distribution
Worldwide distribution: US distribution in TN and country of: Austria.
Location
Reykjavik

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Ossur H / F. Units affected: 4715 units (2 units affected).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2015. Severity: Moderate. Recall number: Z-1322-2015.

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