PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 27, 2016 Initiated: March 14, 2016 #Z-1510-2016

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Ossur H / F
Units Affected
435 total all models
Distribution
Distribution US Nationwide and Hong Kong
Location
Reykjavik, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ossur H / F. Units affected: 435 total all models.
Why was this product recalled?
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 27, 2016. Severity: Moderate. Recall number: Z-1510-2016.