Several implantable spinal fusion stimulator products made by Zimmer Biomet have been recently recalled after test results showed evidence of risks to patients. The recall of the implantable spinal fusion simulator products affects certain serial numbers that were manufactured between Oct. 11, 2016 and Jan. 18, 2017 and distributed between March 28, 2017 and April 6, 2017.

This recall was given Class I status, which is only reserved for products that could be linked to serious complications or death. According to the FDA, the recall was issued due to the affected implantable spinal fusion stimulator products having a “higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs.”

Zimmer Biomet had initiated the recall of these implantable spinal fusion stimulator products on April 20, 2017, when the manufacturing company had sent an Urgent Medical Device Removal letter to healthcare facilities that provide these specific medical devices.

The recall specifically affects the SpF PLUS-Mini and SpF XL Llb Implantable Spinal Fusion Stimulator. Zimmer Biomet had identified 33 different serial numbers affected by the implantable spinal fusion stimulator recall, with Zimmer Biomet instructing physicians and healthcare facilities to quarantine all devices.

Zimmer Biomet had reportedly made the discovery during a typical monitoring procedure, after discovering a high amount of dangerous chemicals in the implantable spinal fusion stimulator products.

The long term complications associated with these products include a risk of cytotoxicity, creating the need for additional procedures and surgeries to fix the damage caused by the side effects.

Overview of Zimmer Biomet Implantable Spinal Fusion Stimulator Complications

The Zimmer Biomet implantable spinal fusion stimulator products are normally used for spinal fusion procedures, with the device used to connect two or more of the vertebrae.

Combined with the use of electrical stimulation applied to the surgical site, the implantable spinal fusion stimulator products are supposed to help fuse vertebrae bones. An implantable spinal fusion stimulator is a medical device that helps promote bone fusion and regrowth. Due to bone being a living tissue like muscle, electrical stimulation in the implantable spinal fusion stimulator products provide the ideal environment for osteogenesis.

It is important to note that spinal fusion surgery is only performed when there are no other treatment options, which is supposed to help restore spinal function within six to twelve months after implantation.

These devices also implement electrical stimulation to help stimulate bone growth in the surgical area, with bone fragments placed between damaged segments of the spine.

According to the recall, risks to patients who have been implanted with these devices may include:

• Cytotoxicity (toxicity of the tissues and organs)
• Chronic Infections
• The need for Revision Surgeries
• Paralysis
• Death

Even though this implantable spinal fusion stimulator recall may prevent future incidents, it does not help patients who have already been injured. Patients who have been allegedly injured by Zimmer Biomet implantable spinal fusion stimulator products may be able to file legal action against the company.