Medical Device Safety and Recalls: Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs

Zimmer Biomet 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. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.

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.

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