Device recall
Z-0475-2016: Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal…
FDA device recall · Class II · Arthrosurface, Inc.
Key facts
| Recall number (Z-number) | Z-0475-2016 |
|---|---|
| Recall event | 72695 |
| Product | Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001). |
| Product code | LZJ |
| Recalling firm | Arthrosurface, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2016 |
| 510(k) numbers | K132496 |
| FEI number | 3004154314 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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