RF Multigen System- Radiofrequency generator

Starting date:

October 12, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-60726

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  Reason
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  Affected products

Affected Products

Reason

The Stryker RF Multigen Generator is part of the interventional spine (IVS) portfolio. The Stryker RF Multigen in combination with the Stryker RF electrodes, cables, and cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. During testing it was found that incorrect information regarding sterilization for the multigen cables is listed in the care instructions and/or instructions for use (IFU) packaged with the Stryker RF Multigen Generator. The care instructions explain information regarding the cleaning and sterilization of the RF Multigen System, including the cables. Previously distributed care instructions/instructions for use incorrectly contained instructions supporting the sterilization of the Multigen cables.

Affected products