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[Recalled] Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. — There is a potential for partial or complete

recall fda device iceland

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductOssur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Brand / manufacturerOssur H / F
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1513-2016
Country of noticeIceland
Risk levelClass II
Hazard typerecall
Notice date14 March 2016

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

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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