[Recalled] RKNXC0003, 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 uni… | FDA 2024-03-25

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

This Class II recall concerns device products distributed in Iceland and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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• RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component — Class II
• Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. — Class II
• Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the he — Class II
• RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component — Class II
• Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.