Device recall
Z-0388-2014: Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is…
FDA device recall · Class II · Synthes USA HQ, Inc.
Key facts
| Recall number (Z-number) | Z-0388-2014 |
|---|---|
| Recall event | 66420 |
| Product | Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of… |
| Product code | LXH |
| Recalling firm | Synthes USA HQ, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2015 |
| FEI number | 3005180112 |
At a glance
- None 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