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GE OEC Medical Systems, Inc recalls The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is
Recalled July 18, 2012 · FDA recall Z-1989-2012 · GE OEC Medical Systems
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. · FDA Class II
Units
15 kits
Sold at
Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Description
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.
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.
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →