RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Reported: May 22, 2024 Initiated: March 25, 2024 #Z-1788-2024
Product Description
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.
Details
- Recalling Firm
- Ossur H / F
- Units Affected
- 143 units
- 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.
- Location
- Reykjavik, N/A
Frequently Asked Questions
What product was recalled? ▼
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component. Recalled by Ossur H / F. Units affected: 143 units.
Why was this product recalled? ▼
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1788-2024.
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