RKN130003 — Class II medical device recall Z-1788-2024
Ongoing recall by Ossur H / F, reported 2024-05-22, distributed nationwide. Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shu
| Recall number | Z-1788-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur H / F, Reykjavik, N/A, Iceland |
| Recall initiated | 2024-03-25 |
| Classified | 2024-05-10 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 143 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05690967595418 |
| Serial numbers | HF365047, HF366857, HF375146, HF375188, HF375583, HF376371, HF376550, HF376791, HF377332, HF377766, HF378019, HF378063, HF378251, HF378272, HF378504, HF378508, HF378541, HF378957, HF379043, HF379062, HF379277, HF379328, HF379484, HF380010, HF380230 and 118 more |
Product
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Reason for recall
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
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-1788-2024. 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.