The FDA announced a recall of Zimmer Biomet’s SpF PLUS Mini and SpF XL IIb implantable spinal fusion stimulators. This is due to the high levels of potentially harmful chemicals that are potentially harmful to tissues and organs (cytotoxicity). The recall of the implantable device affects certain serial numbers that were manufactured between Oct. 11, 2016 and Jan. 18, 2017 and distributed between March 28, 2017 and April 6, 2017. This discovery was made during a routine monitoring procedure. The cytotoxicity can cause chronic infections, long-term hospitalization due to revision surgeries, paralysis, and death. On April 20th, Zimmer Biomet released an urgent Medical Device Removal notification to all of its customers to seek medical treatment to quarantine the devices.
Spinal Fusion Stimulator Failed Cytotoxicity Tests
“A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body,” said the FDA. “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 FDA has labelled this as a Class 1 recall which is the most serious classification of recall. This severity of classification is only reserved for products that could be linked to serious complications or death.
These devices are used during spinal fusion surgery. They increase the possibility of permanently connecting two or more bones of the spine together. They are implanted in patients backs and provide constant electrical stimulation to the surgical site. This assists in fusing the vertebrae bones.
Zimmer Biomet will apparently schedule a time for removal of the quarantined devices from medical facilities by one of their sales representatives. Surgeons who extract these devices should conduct normal clinical monitoring for 3-6 months postoperatively for implanted patients. Hopefully the spinal fusion simulators were recalled in time to avoid adverse health effects in patients. However, with 100,000 of these devices already implanted in patients, that may not be the case.