Ossur H / F: There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

Agency Publication Date: April 19, 2016

Affected Products

Product: Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

P/N: 545100K units from 2008 to current

Product: Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

P/N: 545100L units from 2008 to current

Product: Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

P/N: 545100S units from 2008 to current

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.

P/N: 545150K units from 2008 to current

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.

P/N: 545150L units from 2008 to current

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.

P/N: 545150S units from 2008 to current

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73382

Status: Resolved

Manufacturer: Ossur H / F

Manufactured In: Iceland

Units Affected: 6 products (435 total all models)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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