Device recall
Z-2397-2016: Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled…
FDA device recall · Class II · Zimmer Biomet Spine, Inc
Key facts
| Recall number (Z-number) | Z-2397-2016 |
|---|---|
| Recall event | 74687 |
| Product | Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. |
| Product code | MAX |
| Recalling firm | Zimmer Biomet Spine, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2017 |
| 510(k) numbers | K153695 |
| FEI number | 3012447612 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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