FDA-Device2012-07-18Class II
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.
GE OEC Medical Systems, Inc
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.
Sold states
Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Affected count
15 kits
Manufactured in
384 Wright Brothers Dr, Salt Lake City, UT, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1989-2012Don't want to check this manually?
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