Medical device manufacturer, Zimmer Biomet, recently recalled the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to unsafe levels of potential harmful chemicals which may be toxic to tissues and organs.
The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are devices that are implanted into a patient’s back during spinal fusion surgery to provide constant electrical stimulation to the surgical site. They are meant to increase the possibility of permanently connecting two or more bones of the spine together.
The recall was issued after a positive cytotoxicity test was found during the manufacturer’s routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure that the device is compatible with the human body. A positive cytotoxicity test, which is a failed result, can indicate that a device contains potentially harmful chemicals at levels that could be dangerous to patients.
Serious health consequences may occur with the use of these stimulators, such as chronic infections, paralysis, long-term hospitalization due to additional surgical procedures, and death.
There have been 33 devices recalled in the United States between the manufacturing dates of October 11th, 2016 to January 18th, 2017. The distribution dates of the recalled devices are between March 28th, 2017 to April 6th, 2017.
The FDA has identified this as a Class I recall, which is the most serious type of recall.
For a list of the recalled serial numbers and information on what to do next, please refer to the FDA’s recall notice.