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The U.S. Food and Drug Administration (FDA) has announced a Class I recall of Zimmer Biomet SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators due to higher than allowed levels of potentially cytotoxic chemicals found during routine monitoring procedures.
The stimulators are implanted into the patient's back during spinal fusion procedures, and provide constant electrical stimulation to the surgical site. FDA states that use of the affected products may cause serious adverse health consequences, including but not limited to, chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. Learn more...
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