The Rheo Knee bionic prosthetic is to be used exclusively for… — Class II medical device recall Z-1322-2015
Terminated recall by Ossur H / F, reported 2015-04-01, distributed in TN. The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the s
| Recall number | Z-1322-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur H / F, Reykjavik, Iceland |
| Recall initiated | 2015-02-26 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2015-11-20 |
| Distributed | TN |
| Countries outside the US | AT |
| Model numbers | RKN120007 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1322-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.