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U.S. Department of Health and Human Services

Class 2 Device Recall GEHC OEC Axcess Cranial Pin

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  Class 2 Device Recall GEHC OEC Axcess Cranial Pin see related information
Date Initiated by Firm November 08, 2006
Date Posted July 11, 2012
Recall Status1 Terminated 3 on July 11, 2012
Recall Number Z-1989-2012
Recall Event ID 62397
510(K)Number K051734  
Product Classification Neurological stereotaxic instrument - Product Code HAW
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.
Code Information SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
801-536-4516
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 15 kits
Distribution Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = GE HEALTHCARE TECHNOLOGIES
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