Device recall
Z-2261-2018: P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy…
FDA device recall · Class II · Paragon 28, Inc.
Key facts
| Recall number (Z-number) | Z-2261-2018 |
|---|---|
| Recall event | 80181 |
| Product | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments. |
| Product code | JDR |
| Recalling firm | Paragon 28, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 15, 2021 |
| 510(k) numbers | K170923 |
| FEI number | 3008650117 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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