Device recall
Z-2127-2014: Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System…
FDA device recall · Class II · Small Bone Innovations
Key facts
| Recall number (Z-number) | Z-2127-2014 |
|---|---|
| Recall event | 68445 |
| Product | Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared… |
| Product code | HWC |
| Recalling firm | Small Bone Innovations |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2014 |
| 510(k) numbers | K052576 |
| FEI number | 3003640913 |
At a glance
- 1–9 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