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Ossur H / F

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 recall (Z-0006-2025)Ossur H / F2024-10-01
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component recall (Z-1787-2024)Ossur H / F2024-05-10
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component recall (Z-1788-2024)Ossur H / F2024-05-10
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component recall (Z-1789-2024)Ossur H / F2024-05-10
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component recall (Z-1790-2024)Ossur H / F2024-05-10
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 recall (Z-0788-2024)Ossur H / F2024-01-25
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratc recall (Z-1906-2023)Ossur H / F2023-06-13
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity recall (Z-1322-2015)Ossur H / F2015-03-25
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low prof recall (Z-1288-2015)Ossur H / F2015-03-17
Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external po recall (Z-0965-2012)Ossur H / F2012-02-06

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Every clearance here is in the API, with alerts when new ones post.