The Recall Desk
HighFDA (Devices)·Z-1513-2016·Announced 2016-04-27

Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

Ossur H / F is recalling Lil Angel Vest P3 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device used for cervical spine traction, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

Ossur H / F is recalling the Ossur Lil Angel Vest P3 Kodel, a pediatric-sized support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. The recall involves 435 units of all models, specifically identified by part number 545150K, manufactured from 2008 to the current date.

The recall was initiated because there is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. This defect could compromise the structural integrity of the device used for cervical spine traction.

The affected products were distributed nationwide in the United States and in Hong Kong. Consumers and healthcare providers should stop using the recalled vests and contact the recalling firm for further instructions.

The recalled product

Product
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.
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic / Spinal Support
Hazard
Affected units
435

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • P/N: 545150K units from 2008 to current

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Ossur H / F under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Ossur H / F

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Same hazard · structural failure

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