The Biomet bone growth stimulator products have come under intense scrutiny after the FDA announced a Class I recall.

The FDA stated the recall was issued because the Biomet bone growth stimulator, or the Spinal Fusion Stimulators, may release “higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs.”

Class I recalls are only reserved for medical products that can potentially result in serious injury or death, making certain Biomet bone growth stimulator models potentially dangerous to patients.

The Zimmer Biomet bone growth stimulator recall affects products with certain serial numbers that were manufactured between Oct. 11, 2016 and Jan. 18, 2017, and were distributed between March 28, 2017 and April 6, 2017.

Zimmer Biomet initiated the Biomet bone growth stimulator recall on April 20, 2017, when the company had sent an Urgent Medical Device Removal notification letter to customers. The recall affects the SpF PLUS-Mini and SpF XL Llb Implantable Spinal Fusion Stimulators.

According to Zimmer Biomet, the dangerous chemical levels were discovered during a routine monitoring procedure.

During this time, the company discovered dangerously high levels of certain chemicals that could induce organ or tissue damage. The complications associated with the chemicals inside the Biomet bone growth stimulator products include:

• Cytotoxicity (a toxicity that occurs in tissues and organs)
• Chronic infections
• Long-term hospitalization
• Need for additional surgeries
• Paralysis
• Death

In total, Zimmer Biomet identified 33 different serial numbers affected by the Biomet bone growth stimulator recall.

Hospitals and other healthcare facilities that still have any of the devices affected by the recall are instructed to quarantine them and later arrange for them to be removed from the facilities.

Overview of Zimmer Biomet Bone Growth Stimulator

The Zimmer Biomet bone growth stimulator devices are primarily used for spinal fusion purposes as they help connect patients’ spines. These devices are directly implanted into the patients’ backs during spinal surgery to increase the likelihood that two or more of the vertebrae bones will connect.

The spinal connection process is encouraged through continuously applied electrical charges to the surgical site. Since spinal fusion surgery is a major surgery, physicians only advise this to patients when no other options are possible.

If given proper assistance from the Biomet bone growth stimulator product, the bones should grow together quicker than if unassisted.

According to spine-health.com, the spinal fusion stimulator is a small medical device that is implanted underneath the skin, typically for six to twelve months. This device provides electrical stimulation to the surgical area to help the bone tissue connect faster.

This process is supposed to restore the patient’s spine along with all the vital functions attached to the bone. However, the dangerous chemicals found in the Zimmer Biomet bone growth stimulator could result in potentially fatal complications for patients.

Patients who may have developed tissue or organ damage because of Biomet bone growth stimulator devices may be able to file legal action against the company.