Ossur H / F
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Ossur H / F and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-09FDA-DeviceClass IIMiami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
- 2024-05-22FDA-DeviceClass IIRKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-05-22FDA-DeviceClass IIRKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-05-22FDA-DeviceClass IIRKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-05-22FDA-DeviceClass IIRKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-01-31FDA-DeviceClass IIPower Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
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.
- 2023-06-21FDA-DeviceClass IIIcelock 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-692020
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the lock, leading to loss of suspension of the external prosthetic system that replaces a missing lower limb, which can lead to falling and injury.
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