Product Wiki · Recalls · U.S. FDA — Device Enforcement

The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial… — recall Z-1989-2012

U.S. FDA — Device Enforcement · United States · 2006-11-08 · Class II

As described by U.S. FDA — Device Enforcement: 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 r

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1989-2012
Date of alert
2006-11-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE OEC Medical Systems, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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