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.
This recall has been terminated (originally issued March 14, 2016).
- Recall Initiated
- March 14, 2016
- Terminated
- August 16, 2016
- Recall Number
- Z-1512-2016
- Quantity
- 435 total all models
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Distribution
Distribution US Nationwide and Hong Kong
Lot / Code Info
P/N: 545100S units from 2008 to current
Root Cause
Component design/selection
Action Taken
Customer notification letter were sent on 03/14/16 via traceable method. The notification asked customers to examine their inventory, quarantine product subject to the recall and contact customer service for a return authorization to return the product to Ossur. Customers were asked to take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the potentially affected devices have been transferred. 2. Maintain awareness on the notice for an appropriate period. 3. If have further distributed this product identify the customers and notify them at once of this product alert. It is recommended that a copy of the notice is included. 4. If any customers are currently wearing a product it is recommended a detailed inspection of the product vest structurebe conducted to ensure there is no visible cracks on the vest.