FDAMarch 25, 2024device
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
What to do
FDA enforcement status: Ongoing
Brands named
ossur h fossur
UPCs
05690967595418
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMiami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-1012024-08-20
- FDARKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDARKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDARKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDAPower Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA100022023-12-26
- FDAIcelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-6920202023-05-12
- FDAOSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T2022-08-29
- FDAOSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.2022-05-30
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