FDAFDA · Food and drugs·Recall number Z-1989-2012
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.
Published July 18, 2012 · Recall initiated: November 8, 2006
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- GE OEC Medical Systems, Inc
- Distributor
- Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
- Lot
- SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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