Food, drugs, devices › GE OEC Medical Systems, Inc
Device recall: The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is
GE OEC Medical Systems, Inc (Salt Lake City, UT) initiated this device recall on 8 Nov 2006; FDA lists 1 product record under event 62397, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 10 device enforcement events initiated in 2006 carry the same class.
Status: Terminated, terminated 11 Jul 2012. Initiation: voluntary: firm initiated. GE OEC Medical Systems, Inc has 28 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE OEC Medical Systems, Inc, Salt Lake City, UT.
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."
Distribution
"Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | 15 kits | Class II | Terminated | 18 Jul 2012 |
Context
Other enforcement events for GE OEC Medical Systems, Inc
All 28 events for GE OEC Medical Systems, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Jul 2012. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.