Recall Z-1989-2012— GE OEC Medical Systems, Inc

Name: FDA recall Z-1989-2012
Creator: U.S. Food and Drug Administration
Published: 2006-11-08

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2006-11-08, terminated 2012-07-11. It names one FDA 510(k) clearance: K051734. Product: 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..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2006-11-08
Terminated: 2012-07-11
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K051734 — GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955Ge Healthcare Technologies·cleared 2005-11-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.