Enforcement Report - Week of July 18, 2012
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Event Detail
| Event ID | 62397 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | GE OEC Medical Systems, Inc |
| City | Salt Lake City |
| State | UT |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2006-11-08 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549, | Class II | 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. | 15 kits | Z-1989-2012 |
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