Device recall
Z-0556-2009: External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84…
FDA device recall · Class II · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0556-2009 |
|---|---|
| Recall event | 49510 |
| Product | External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86 Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation. |
| Product code | KTT |
| Recalling firm | Sterilmed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| 510(k) numbers | K051957 |
| FEI number | 3001237663 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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