FDA Enforcement
Class II
Terminated
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: Z-1989-2012
·
Reported July 18, 2012
Enforcement
- Recall Number
- Z-1989-2012
- Event ID
- 62397
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE OEC Medical Systems, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- July 18, 2012
- Initiation Date
- November 8, 2006
- Classification Date
- July 11, 2012
- Termination Date
- July 11, 2012
- Address
- 384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862, United States
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.
Reason
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.
Code Info
SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549,
Distribution
Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Quantity
15 kits