Device product
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Z-1515-2016
Product summary
- Firm
- Ossur H / F
- Event
- Event 73382
- Status
- Terminated
- Classification
- Class II
- Quantity
- 435 total all models
- Official record key
device-enforcement:Z-1515-2016
Official wording
Reason: There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Code information: P/N: 545150S units from 2008 to current
Distribution pattern: Distribution US Nationwide and Hong Kong
Derived failure modes
-
Unknown
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.