Device recall
Z-1146-2015: Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set…
FDA device recall · Class II · Biomet Spine, LLC
Key facts
| Recall number (Z-number) | Z-1146-2015 |
|---|---|
| Recall event | 70383 |
| Product | Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile… |
| Product code | NKB |
| Recalling firm | Biomet Spine, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2015 |
| 510(k) numbers | K122145 |
| FEI number | 3012447612 |
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