Recall Z-1513-2016 ยท KQZ Component, Traction, Non-Invasive
Ossur H / F
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.
| Date | Mar 14, 2016 |
| Status | Terminated |
| Reason | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 435 total all models |
| Distribution | Distribution US Nationwide and Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.