Device recall
Z-1989-2012: The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a…
FDA device recall · Class II · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-1989-2012 |
|---|---|
| Recall event | 62397 |
| Product | The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is… |
| Product code | HAW |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2012 |
| 510(k) numbers | K051734 |
| FEI number | 1720753 |
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