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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1989-2012
Classification Class II
Code Info SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549,
Product Distributed Qty 15 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.

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