FDA-Device2016-04-27Class II

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.

Ossur H / F
Hazard

There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

Sold states
Distribution US Nationwide and Hong Kong
Affected count
435 total all models
Manufactured in
Grjothals 5, N/A, Reykjavik, N/A, Iceland
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2016

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