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U.S. Department of Health and Human Services

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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