The Food and Drug Administration recently announced that Zimmer Biomet is recalling its SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators after a routine monitoring procedure revealed high levels of potentially harmful chemicals, according to Harris Martin Publishing.
Spinal Fusion Stimulator devices are implanted into a patient’s back during spinal fusion surgery to increase the likelihood of permanently connecting bones in the spine together.
After Zimmer found levels of chemicals above the allowed amount during the devices’ cytotoxicity tests, the FDA issued a MedWatch alert on May 30. The alert stated that the chemicals may be toxic to tissues and organs, potentially causing chronic infections, additional surgeries that would require long-term hospitalization, paralysis, and death.
A cytotoxicity test is one way medical devices are evaluated, as it measures the compatibility of the device with the human body. When a device fails a cytotoxicity test, it can indicate that the device contains potentially harmful chemicals in amounts that could be dangerous to the patient, as reported by Harris Martin Publishing.
On April 20, Zimmer sent an Urgent Medical Device Removal notification to all of its affected customers, instructing them to quarantine all affected devices until Zimmer sales representatives could remove them from the facility.
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