Ossur H / F: Medical Device Recall in 2016 - (Recall #: Z-1512-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 14, 2016

Date Posted: April 27, 2016

Recall Number: Z-1512-2016

Event ID: 73382

Reason for Recall:

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

Status: Terminated

Product Quantity: 435 total all models

Code Information:

P/N: 545100S units from 2008 to current

Distribution Pattern:

Distribution US Nationwide and Hong Kong

Voluntary or Mandated:

Voluntary: Firm initiated