Z-1989-2012Class II

The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling...

Name: Z-1989-2012 The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling...
Creator: GE OEC Medical Systems, Inc
Published: 2006-11-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-11-08 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of 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... on 2006-11-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1989-2012
Classification: Class II
Status: Terminated
Initiated: 2006-11-08
Posted: 2012-07-11
Terminated: 2012-07-11
Recalling firm: GE Healthcare
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 required.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare sent an "URGENT REMOVAL NOTICE" dated November 8, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer Service at 1-800-874-7378 for questions regarding this recall.
Quantity in commerce: 15 kits
Distribution: Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Product codes and lots: SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1989-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1989-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11

Product code HAW

K051734Class IIGe Healthcare Insta Trak 3500Plus/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955Ge Healthcare Technologies / cleared 2005-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)