Recall Z-1989-2012 ยท HAW Neurological Stereotaxic Instrument
GE OEC Medical Systems, Inc
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.
| Date | Jul 11, 2012 (initiated Nov 8, 2006) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 15 kits |
| Distribution | Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051734 | GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 Ge Healthcare Technologies, Nov 23, 2005 |