FDA Device recall Z-1322-2015
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations by Ossur H F, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1322-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-26 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ossur H F |
| Distribution | TN |
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.
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.
Identifiers
| code_info | Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1322-2015%22
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