GE OEC Medical Systems, Inc: Medical Device Recall in 2012 - (Recall #: Z-1989-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 8, 2006

Date Posted: July 18, 2012

Recall Number: Z-1989-2012

Event ID: 62397

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.

Status: Terminated

Product Quantity: 15 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated