Device recall
Z-1720-2014: SBi RingFix Olive Wires Product Usage: These are temporary devices indicated…
FDA device recall · Class II · Small Bone Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-1720-2014 |
|---|---|
| Recall event | 68039 |
| Product | SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy. |
| Product code | KTT |
| Recalling firm | Small Bone Innovations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2014 |
| 510(k) numbers | K071394 |
| FEI number | 3003640913 |
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