The Recall Desk
HighFDA (Devices)·Z-1514-2016·Announced 2016-04-27

Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

Ossur H / F is recalling Lil Angel Vest P3 Lambswool units because the plastic stabilizer strap may fracture. The recall covers 435 units distributed in the US and Hong Kong.

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 medical device with a structural defect (fracture) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Ossur H / F is recalling the Ossur Lil Angel Vest P3 Lambswool, a pediatric-sized support structure used with the halo system for cervical spine traction. The recall involves 435 total units across all models, specifically those with part number 545150L manufactured from 2008 to the present.

The recall is being issued because there is a potential for the plastic stabilizer strap on the vest to partially or completely fracture. This product was distributed nationwide in the United States and in Hong Kong.

Consumers should stop using the affected vests immediately. The source text does not specify further consumer instructions or contact information for the recall.

The recalled product

Product
Ossur Lil Angel Vest P3 Lambswool. 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 / Cervical 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: 545150L 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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