| Class 2 Device Recall GEHC OEC Axcess Cranial Pin | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HAW
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