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[Recalled] Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 — Knee batteries may need replacement with conforming batteries to ensure there i… | FDA 2023-12-26

recall fda device iceland

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductPower Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Brand / manufacturerOssur H / F
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0788-2024
Country of noticeIceland
Risk levelClass II
Hazard typerecall
Notice date26 December 2023
EAN / barcode05690967648381

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

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 →

Related recalls from Ossur H / F

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.

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