Device recall
Z-0674-2008: Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor…
FDA device recall · Class II · Orthofix, Inc
Key facts
| Recall number (Z-number) | Z-0674-2008 |
|---|---|
| Recall event | 45878 |
| Product | Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069. |
| Product code | LXT |
| Recalling firm | Orthofix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 20, 2008 |
| 510(k) numbers | K941048 |
| FEI number | 2183449 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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