Z-1513-2016 Class II Terminated
FDA device recall Z-1513-2016 was initiated by Ossur H / F on March 14, 2016 and is designated Class II. Reason for recall: There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. The recall status is terminated (terminated August 16, 2016). Affected quantity: 435 total all models.
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 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.
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: 545150K units from 2008 to current