The FDA has recently announced a recall of the Zimmer Biomet SpF stimulator, alleging that it can be toxic to tissues and organs.

The Zimmer Biomet SpF stimulator is a bone growth stimulator often implanted into patients after spinal fusion surgery. It is a small medical device that delivers electronic stimulation to the bone in areas where it needs to grow together following a surgery.

Zimmer Biomet’s website claims that over 100,000 Biomet SpF stimulators have been implanted. Patients who have received these devices reportedly enjoy a 50% increase in the success rate of bone fusion, and it reportedly improves the fusion success rate in patients who have certain risk factors.

It is intended to be a temporarily implanted device and should be removed after 6 months or when the need for it has passed.

However, Zimmer Biomet’s own in-house testing has unearthed other information that has led to a Class I recall of the devices.

Biomet SpF Stimulator Recall

In April 2017, the U.S. Food and Drug Administration announced a Class I recall for the Biomet SpF stimulator models. This recall affects the SpF PLUS-Mini and SpF XL LLb Implantable Spinal Fusion Stimulators manufactured between Oct. 11, 2016 and Jan. 18, 2017. Thirty-three different serial numbers are affected by this Class I recall.

An FDA Class I recall is issued when there is a situation in which there is a good chance that the use or exposure to a certain product or device will either cause severe health consequences or death.

When someone undergoes spinal fusion surgery, the surgeons intend for certain parts of a patient’s spine to grow together. This can be a solution for severe back pain that can be addressed in no other way.

Like skin and muscle, bone is a living tissue. If it is given the right stimulation, it will grow together. The surgeon places bone fragments between the parts of the spine that are meant to be fused together.

The doctor may then place a spinal fusion stimulator under the skin near the fusion point. This delivers electric pulses to the site where the bone should grow together and over time, usually 6 to 12 months, the bone begins to fuse. This process is called osteogenesis, or the body growing bone tissue.

But in the regular course of product testing, Zimmer Biomet discovered a potential problem regarding the Biomet SpF stimulator in particular. They found that harmful chemicals from the medical devices may leach into the surrounding tissue and bone, resulting in a condition known as cytotoxicity.

The FDA classifies this cytotoxicity as comprising of “higher than allowed levels of potential harmful chemicals,” and explains that at cytotoxicity test is a part of a biological evaluation of medical devices to see if it is compatible with the human body.

The FDA notes that use of the Biomet SpF stimulator can “cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis and death.”

If you or someone you love has had spinal fusion surgery in which a Biomet SpF stimulator was used, you may have a legal claim.