# FDA recall Z-1787-2024

> **Ossur H / F** · Class II · device recall initiated 2024-03-25.

## Product

RKN130002, RHEO KNEE 2 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.

## Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, 	WI, WV, WY.

## Key facts

- **Recall number:** Z-1787-2024
- **Recalling firm:** Ossur H / F
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-25
- **Report date:** 2024-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reykjavik, N/A, Iceland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1787-2024

## Citation

> AI Analytics. FDA recall Z-1787-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1787-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*