FDADecember 26, 2023device
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
What to do
FDA enforcement status: Ongoing
Brands named
ossur h fossur
UPCs
056909676483810569096764874905690967648404
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
- FDARKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component2024-03-25
- FDARKN130003, RHEO KNEE 3 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
- 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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