Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1788-2024 — RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

U.S. FDA — Device Enforcement · Iceland · 2024-03-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1788-2024
Date of alert
2024-03-25
Country / jurisdiction
Iceland
Risk level
Class II
Risk type
recall
Brand
Ossur H / F
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05690967595418
Reported risk: Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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