The Recall Desk
HighFDA (Devices)·Z-1515-2016·Announced 2016-04-27

Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

Ossur H / F is recalling Lil Angel Vest P3 Sorbatex units because the plastic stabilizer strap may partially or completely fracture.

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, posing a risk of harm if the strap fractures, but no injuries or illnesses are reported in the source text.

Plain-English summary

Ossur H / F is recalling the Lil Angel Vest P3 Sorbatex, 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 total units across all models, specifically those with part number 545150S manufactured from 2008 to the present. These products were distributed nationwide in the United States and in Hong Kong.

The recall is being conducted because there is a potential for the plastic stabilizer strap on the vest to partially or completely fracture. This defect could compromise the structural integrity of the device used for cervical spine traction.

Consumers who have this product should stop using it and contact the recalling firm for instructions on how to proceed.

The recalled product

Product
Ossur Lil Angel Vest P3 Sorbatex. 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 / Traction
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: 545150S 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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