FDAFDA · Food and drugs·Recall number Z-1513-2016
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.
Published April 27, 2016 · Recall initiated: March 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ossur H / F
- Distributor
- Distribution US Nationwide and Hong Kong
- Lot
- P/N: 545150K units from 2008 to current
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Iceland
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