GE Axcess Cranial Screw Recalled Due to Breakage During Insertion
GE Healthcare is recalling 15 kits of Axcess Cranial Screws because they may break during insertion, posing a potential health hazard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (breakage leading to health hazard) where specific injuries or illnesses have not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling 15 kits of the Axcess Cranial Screw, a self-tapping, self-drilling screw used as an accessory with the Axcess Cranial Tri-Pin Kit. The device is intended for rigid fixation of a tracking device to bone. The recall is due to instances where the screws have broken during insertion.
The company states there is a possibility that the breaking of the screws could lead to a health hazard. The affected products were distributed in Washington, D.C., and the states of Alabama, California, Florida, New York, Oregon, and Virginia.
Healthcare facilities should contact GE Healthcare for instructions on how to return the affected devices. Consumers should not use the recalled screws and should contact their healthcare provider if they have had the device implanted.
The recalled product
- 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…
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- SOT-004
- SOT-005
- SWT-007
- SWT-008
- SWT-009
- SWT-010
- SWT-012
- SWT-013
- 1W9239/1
- 0549
Distribution
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