Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The Axcess Cranial Screw (sometimes referred to as the Axcess Recalled by GE OEC Medical Systems, Inc Due to GE Healthcare is aware of a few instances...

Date: November 8, 2006
Company: GE OEC Medical Systems, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE OEC Medical Systems, Inc directly.

Affected Products

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.

Quantity: 15 kits

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 6 states: AL, CA, FL, NY, OR, VA

Affected (6 states)Not affected

About GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc has 48 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report