Recall Z-1510-2016
Ossur H / F · initiated March 14, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Codes / lots: P/N: 545100K units from 2008 to current
Reason for recall
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
FDA-determined 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.
Details
- Recall number
- Z-1510-2016
- Initiated
- March 14, 2016
- Terminated
- August 16, 2016
- Product code
- KQZ – Component, Traction, Non-Invasive
- Quantity
- 435 total all models
- Distribution
- Distribution US Nationwide and Hong Kong
- Recalling firm
- Ossur H / F, Reykjavik
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1511-2016 Class II | Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | 03/14/2016Terminated |
| Z-1512-2016 Class II | Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | 03/14/2016Terminated |
| Z-1513-2016 Class II | Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | 03/14/2016Terminated |
| Z-1514-2016 Class II | Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | 03/14/2016Terminated |
| Z-1515-2016 Class II | Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | 03/14/2016Terminated |