The U.S. Food and Drug Administration (FDA) recently announced a recall of the Zimmer Biomet implantable spinal fusion stimulator over dangerous complications, and classified this as a Class I recall.

What is an Implantable Spinal Fusion Stimulator?

An implantable spinal fusion stimulator is a device implanted during spinal fusion surgery to encourage two or more spinal bones to fuse together. The device uses electrical stimulation applied to the surgical site.

However, Zimmer Biomet has reported “higher than allowed levels of potentially harmful chemicals” linked with the device, which can cause toxicity issues for surrounding tissue and organs.

Implantable Spinal Fusion Stimulator Recall

The FDA announced the recall of the implantable spinal fusion stimulator on April 20, 2017. Zimmer Biomet also issued an Urgent Medical Device Removal notification to its customers.

The federal agency classified the recall of the implantable spinal fusion stimulator as a Class I recall. While Class II recalls indicate that a device or drug causes temporary harm, Class I recalls are reserved for products that can cause serious injury or even death.

According to the FDA announcement, Zimmer Biomet found potentially harmful chemicals could be released from their implantable spinal fusion stimulator devices at higher than allowed levels. These high chemical levels can cause cytotoxicity (affecting tissue and organs), chronic infections, long-term hospitalization, paralysis, and death.

The specific Zimmer Biomet implantable spinal fusion stimulator devices involved in the recall are the following:

• SpF PLUS-Mini Implantable Spinal Fusion Stimulator
• SpF XL Llb Implantable Spinal Fusion Stimulator

Implantable spinal fusion stimulator devices affected include 33 different serial numbers manufactured between Oct. 11, 2016 and Jan. 18, 2017. These devices would have been distributed between March 28, 2017 and April 6, 2017.

The FDA noted that surgeons should observe patients that have already been implanted with these implantable spinal fusion stimulator devices for three to six months after operation to ensure safety.

If any of these devices remain in medical facilities’ inventories, the FDA has instructed medical providers to quarantine them so that they cannot be implanted in any more patients.

Filing an Implantable Spinal Fusion Stimulator Lawsuit

If you or someone you love has recently had an implantable spinal fusion stimulator implanted in your back, you may be able to file a lawsuit against Zimmer Biomet. While filing a claim cannot take away the pain and suffering experienced from injuries caused by a implantable spinal fusion stimulator, it can help to alleviate the financial burden that can be caused by medical expenses and lost wages.