The recall applies to Zimmer Biomet’s SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products. Specifically pertains to 33 units, with different serial numbers, distributed between March 28, 2017 and April 6, 2017, and manufactured between October 11, 2016 and January 18, 2017.
The higher than allowed cytotoxicity levels found during the company’s routine monitoring means it caused a toxic reaction in the body and can be destructive to cells.
According to the FDA, these stimulators potential harmful chemicals may cause the following complications:
- Chronic infections
- A need for additional surgeries that can require extended hospital stays
- And, in some cases, even death.
The device is meant to help in the healing of spinal fusion surgery, but instead was causing more pain and problems.
If you or a loved one recently had a spinal fusion stimulator surgically implanted in the back and have suffered side-effects, you may be eligible for compensation for pain, suffering, and medical bills.
Medical device manufacturers must put people over profit.
Zimmer has a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If the company failed to do this, it should be held responsible for injuries and the consequences of not warning the risks posed by their products or should have known of the problems.
At Greg Jones Law, we’re available to hold the manufacturer liable, to pay medical expenses, lost wages, pain and suffering and any permanent disability caused by these implants.
Greg Jones Law has the expertise and the resources to stand by patients and all affected by these spinal implants. We have a proven track record of helping victims of dangerous drugs and medical devices.
So, if you or a loved one has serious problems due to the Zimmer Biomet Spinal Fusion Stimulator, contact us or fill out the form on the webpage. You will get a free, no obligation consultation.
We can take your case without the need to put any money upfront and no legal fees unless you get compensated. We’re here to help.