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
- Recall Number
- Z-1989-2012
- Event Number
- 62397
- Firm
- GE OEC Medical Systems, Inc
- FEI Number
- 1720753
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 8, 2006
- Posted
- July 11, 2012
- Terminated
- July 11, 2012
- Address
- 384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862
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.
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.
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.
Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
15 kits