FDA Class 1 Recall of Zimmer Biomet Implantable Spinal Fusion Stimulators

Washington, DC: Zimmer Biomet, in conjunction with the US Food and Drug Administration (FDA), is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure.

According to a statement issued by the FDA, the use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death.

The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine (backbone) together. The device is implanted into the patient's back and provides constant electrical stimulation to the surgical site.

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Published on May-30-17