A bone fusion stimulator is under recall due to a possibility of chemical poisoning.

Zimmer Biomet has recalled several batches of its SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators manufactured between Oct. 11, 2016 and Jan. 18, 2017.

The bone fusion stimulator is implanted during some spinal fusion surgeries to increase the probability of connecting two or more vertebrae together. The device provides electrical stimulation to the surgical site.

Bone Fusion Stimulators Under Recall

The FDA has identified the bone fusion stimulator recall as a Class I recall, which is the most serious level of recall reserved for devices that may cause serious injuries or death.

According to the FDA, these Zimmer Biomet products “have higher than allowed levels of harmful chemicals, which may be toxic to tissues and organs (cytotoxicity).” This possibility was determined during a routine monitoring procedure. A cytotoxicity test is one of the biological evaluations that must be done to ensure a medical device is compatible with the human body.

The two affected models of the bone fusion stimulator may cause “adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death,” warns the FDA.

Zimmer Biomet sent an Urgent Medical Device Removal notification to affected patients on April 20, 2017. Surgeons were reminded to continue clinical monitoring for up to six months post-operatively of any patient who had received an implanted bone fusion stimulator.

The company issued a list of 33 serial numbers covered under the recall. Medical facilities that still have any of the affected bone fusion stimulators on their shelves have been asked to quarantine the devices, which will be picked up by Zimmer Biomet representatives at a designated time.

In marketing the bone fusion stimulators, Zimmer Biomet claimed “a proven 50% increase in success rates over autograft alone” and noted its SpF model “features a 43% smaller generator with a slimmer, lower-profile design for enhanced patient comfort and more placement options.”

Spinal fusion is major surgery that often takes several hours to complete. The resulting fusion of the vertebrae stops motion at the affected segment of the spine in order to stop pain.

If you or someone you know has undergone back surgery that included implantation of a bone fusion stimulator that has resulted in any of the described problems, you could qualify for this Zimmer Biomet class action lawsuit investigation.