The SpF stimulator is implanted during spinal surgery to fuse individual vertebra together. It gives strategic electrical stimulation to the surgical site to encourage two or several of the bones in the back to permanently bond as a unit. The aim of spinal fusion surgery is to this end, but it is not always successful.

The Zimmer Biomet SpF Stimulator was recently quarantined and pulled off the market after being subject to a recall classified as Class I by the Food and Drug Administration (FDA). The Class I recall is a status reserved for medical devices and pharmaceuticals that can cause irreversible physical damage and injury and possible death.

The manufacturing company itself started the process of the recall by sending out an emergency notification to its customer base requiring removal of the SpF stimulator that fell within a specified range of serial numbers made between Oct. 11, 2016 and Jan. 28, 2017.

Fortunately, that serial number range had a small window of distribution between March 28 and April 6, 2017.

Zimmer Biomet SpF Stimulator Found To Cause Cytotoxicity

The Zimmer Company, originally founded in 1927 with the aim of making aluminum splints, is a worldwide medical device manufacturing company based out of Warsaw, Indiana. It has built a business of developing and manufacturing knee, hip, foot and ankle, and shoulder and elbow prosthetic units.

The company has been belabored by a number of product recalls, frequently by its own initiation as is the case with the Biomet SpF stimulator. The product was engaged in a process of routine company monitoring when it was discovered that the electrical device had many potentially toxic chemicals that could leach into the tissues after implantation, causing severe damage.

Being toxic to cells, also known as cytotoxicity, can cause necrosis or tissue death. According to the FDA, use of the SpF stimulator with its potential for cytotoxicity found during testing could lead to serious medical events (SME) leading up to and including death.

Less serious consequences of device use might be ongoing infections, repeat hospitalizations for more surgeries, loss of income-earning ability and incurring medical bills secondary to the same, and potential paralysis.

The Class I recall was issued on April 20, 2017. It affects two SpF stimulator models known as the SpF PLUS-mini and SpF XL LLb by Zimmer Biomet. According to the FDA, there have been 33 serial numbers of the two models distributed as listed below.

SpF PLUS-mini: 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, 410171

SpF-XL LLB: 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667

While it is unknown if any spinal fusion stimulator lawsuits have been filed against the Zimmer Biomet over the SpF Stimulator, a current investigation is underway. If you have questions regarding this recall, you can contact Zimmer Biomet at 1-800-447-3625 or report an adverse medical event through the FDA website.

Patients who believe they have suffered complications linked to these spinal fusion stimulators may also qualify for a free initial consultation with a knowledgeable medical device attorney.