Z-1512-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2016
- Initiation Date
- March 14, 2016
- Termination Date
- August 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 435 total all models
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.
Reason for Recall
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Distribution Pattern
Distribution US Nationwide and Hong Kong
Code Information
P/N: 545100S units from 2008 to current