FDA Device recall Z-1788-2024
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
- FDA Device
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component by Ossur H F, citing due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1788-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-25 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ossur H F |
| Distribution | US |
Product
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Reason
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Identifiers
| code_info | UDI: 05690967595418/ Serial Numbers: HF383471 HF383327 HF383283 HF366857 HF383410 HF375146 HF365047 HF375188 HF383312 H…UDI: 05690967595418/ Serial Numbers: HF383471 HF383327 HF383283 HF366857 HF383410 HF375146 HF365047 HF375188 HF383312 HF375583 HF383377 HF376371 HF383431 HF376550 HF383493 HF376791 HF383276 HF377332 HF383294 HF377766 HF383319 HF378019 HF383346 HF378063 HF383387 HF378251 HF383419 HF378272 HF383437 HF378504 HF383485 HF378508 HF383506 HF378541 HF383273 HF378957 HF383281 HF379043 HF383291 HF379062 HF383310 HF379277 HF383315 HF379328 HF383321 HF379484 HF383342 HF380010 HF383355 HF380230 HF383384 HF380398 HF383395 HF380403 HF383412 HF380450 HF383426 HF380510 HF383434 HF381405 HF383445 HF381419 HF383482 HF381429 HF383488 HF381443 HF383503 HF381512 HF383509 HF381970 HF383268 HF382159 HF383274 HF382314 HF383279 HF382346 HF383282 HF382371 HF383285 HF382395 HF383292 HF382481 HF383309 HF382878 HF383311 HF383192 HF383314 HF383193 HF383316 HF383194 HF383320 HF383195 HF383322 HF383196 HF383328 HF383198 HF383344 HF383200 HF383352 HF383210 HF383376 HF383216 HF383383 HF383218 HF383385 HF383219 HF383388 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1788-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.