Device recall
Z-2085-2016: Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number…
FDA device recall · Class II · Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Key facts
| Recall number (Z-number) | Z-2085-2016 |
|---|---|
| Recall event | 74275 |
| Product | Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications. |
| Product code | HBE |
| Recalling firm | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 13, 2017 |
| 510(k) numbers | K081475 |
| FEI number | 1625507 |
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