The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, sel...
FDA Recall #Z-1989-2012 — Class II — November 8, 2006
Product Description
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.
Reason for Recall
GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. There is a possibility that breaking of the screws could lead to a health hazard.
Recalling Firm
GE OEC Medical Systems, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 kits
Distribution
Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Code Information
SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549,
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated