The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is
FDA device recall Z-1989-2012 · posted 2012-07-11 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 15 kits
- Distribution
- Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
- Date initiated
- 2006-11-08
- Date posted
- 2012-07-11
- Date terminated
- 2012-07-11
- Location
- Salt Lake City, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 (K051734) | Ge Healthcare Technologies | 2005-11-23 |