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.
FDA Recall Z-1989-2012 · Posted 2012-07-11
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Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2006-11-08
Date Terminated2012-07-11
Product Quantity15 kits
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.
Firm Action
GE Healthcare sent an "URGENT REMOVAL NOTICE" dated November 8, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer Service at 1-800-874-7378 for questions regarding this recall.
Root Cause
Device Design
Distribution Pattern
Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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