Device recall
Z-1298-2016: Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100…
FDA device recall · Class II · Ossur H / F
Key facts
| Recall number (Z-number) | Z-1298-2016 |
|---|---|
| Recall event | 73380 |
| Product | Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and… |
| Product code | IQK |
| Recalling firm | Ossur H / F |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| FEI number | 3003764610 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database