Device Recall GEHC OEC Axcess Cranial Pin

SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549.

Neurological Devices

2

No

Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA

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 required.