Device recall
Z-0590-2011: Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011…
FDA device recall · Class III · Orthofix Inc
Key facts
| Recall number (Z-number) | Z-0590-2011 |
|---|---|
| Recall event | 57011 |
| Product | Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle. |
| Product code | LWE |
| Recalling firm | Orthofix Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 28, 2011 |
| 510(k) numbers | K913306 |
| FEI number | 2183449 |
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