On May 30, 2017, the FDA announced a Class I recall for the Zimmer Biomet SpF spinal fusion stimulator. This type of recall is the most serious type of recall that the FDA issues due to the fact that using these devices may lead to serious injuries or even death.

The SpF spinal fusion stimulator is surgically implanted during spinal fusion surgeries to promote a greater likelihood that the bones in the spine will fuse together. The device is implanted in the area near the spine and generates electrical impulses in order to encourage bone growth. Patients do not feel any painful or electrical sensations when this device is implanted.

The FDA issued its recall of the SpF spinal fusion stimulator because it was determined that the device has “higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs.” The FDA goes on to state that the outcome of having these toxic levels of chemicals in the body from the SpF stimulator could lead to problems such as ”chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death.”

Prior to the FDA recall, Zimmer Biomet sent its own communication to medical customers on April 20, 2017. This Urgent Medical Device Removal summarized the reason for the removal and indicated that the products should be quarantined so that Zimmer Biomet sales representatives can then come to remove the products from the medical facility.

Zimmer Biomet stated that they had identified the issues relating to the higher levels of potentially harmful chemicals while performing a routine procedure to monitor the devices. According to the FDA, the devices failed a cytotoxicity test which is one of the ways that medical devices are evaluated to ensure that they are compatible with the human body.

“A positive cytotoxicity test (failed test) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient,” the FDA warning states.

Approximately 33 devices were affected, and these SpF spinal fusion stimulator devices were manufactured between Oct. 11, 2016 and Jan. 18, 2017. They were distributed between March 28, 2017 and April 6, 2017. A total of 22 different serial numbers were included in the recall as listed on the FDA website.

The notification sent by Zimmer Biomet reminded surgeons that patients who have already received the SpF spinal fusion stimulator should be receiving normal clinical monitoring for the three to six months following the operation.

Were You Implanted with a Recalled Zimmer Biomet SpF Spinal Stimulator?

If you have been implanted with a recalled Zimmer Biomet SpF spinal stimulator, you may be eligible to seek legal compensation from the product manufacturer. Manufacturers have a duty to produce products that are safely and effectively designed and manufactured, and patients must be properly warned of any potential safety issues.

Patients may choose to bring forth lawsuits against the manufacturer for products that are defective in their design, manufacture, or marketing, as is the case when a company fails to warn. An experienced attorney can review your case to determine if you qualify to file an SpF spinal fusion stimulator lawsuit.