Device recall
Z-0592-2017: Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage…
FDA device recall · Class II · Alphatec Spine, Inc.
Key facts
| Recall number (Z-number) | Z-0592-2017 |
|---|---|
| Recall event | 75337 |
| Product | Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System… |
| Product code | NKB |
| Recalling firm | Alphatec Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2017 |
| 510(k) numbers | K133221 |
| FEI number | 2027467 |
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