Ossur H / F: Medical Device Recall in 2015 - (Recall #: Z-1322-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 26, 2015

Date Posted: April 1, 2015

Recall Number: Z-1322-2015

Event ID: 70693

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.

Status: Terminated

Product Quantity: 4715 units (2 units affected)

Code Information:

Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498

Distribution Pattern:

Worldwide distribution: US distribution in TN and country of: Austria.

Voluntary or Mandated:

Voluntary: Firm initiated