A Medical Device Daily
Medtronic (Minneapolis) said the FDA has classified its voluntary recall action of the Intrepid Intervertebral Body Fusion device as a Class II recall. Medtronic initiated a voluntary recall of the product in February 2009, and communicated the risk to physicians and hospitals. Medtronic confirms that all unused product has been retrieved and the company has received confirmation of notification from all affected physicians and hospitals.
The Intrepid Intervertebral Body Fusion device is intended to provide stabilization of the vertebral bodies and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.
The device was recalled because, upon review of the clinical experience, Medtronic had determined that there was a need to revise the labeling and modify the device design.
Medical assessment indicates that use of the device without adherence to the revised labeling criteria or without a cover plate creates a risk that the implant could become unstable which could, in turn, possibly lead to the need for revision surgery. Given the close proximity of major blood vessels in the lumbar spine region, such revision surgery has the potential for serious complications.