Device recall
Z-0034-2012: Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot #…
FDA device recall · Class II · X Spine Systems Inc
Key facts
| Recall number (Z-number) | Z-0034-2012 |
|---|---|
| Recall event | 59756 |
| Product | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| Product code | FZS |
| Recalling firm | X Spine Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2013 |
| 510(k) numbers | K101471 |
| FEI number | 3005031160 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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