Device recall
Z-0967-2018: SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS…
FDA device recall · Class II · ORTHO SOLUTIONS, LTD.
Key facts
| Recall number (Z-number) | Z-0967-2018 |
|---|---|
| Recall event | 79218 |
| Product | SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS… |
| Product code | HWC |
| Recalling firm | ORTHO SOLUTIONS, LTD. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2018 |
| 510(k) numbers | K163489 |
| FEI number | 3008951116 |
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