The FDA has announced Zimmer Biomet’s Class 1 Recall of the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators. The reason behind the recall is a risk for chronic infections, paralysis, long-term hospitalization due to additional surgical procedures, and death.
The devices, used during spinal fusion surgery, were determined to contain higher-than-allowed levels of potentially harmful chemicals. These chemicals may be toxic to organs and tissue, causing major complications such as those listed above. The discovery was recently made during routine monitoring. The SpF PLUS-Mini and SpF XL IIb’s intended use is to permanently connect two or more spinal bones together. It is inserted into the patient’s back to provide consistent electrical stimulation to the surgical site.
Zimmer Biomet is unfortunately familiar with the recall process. It’s Comprehensive Reverse Shoulder Replacement was also pulled off the market as part of a Class 1 Recall. Zimmer also has a history of issues with its NexGen and Persona knee replacements, which were issued Class 2 recalls due to the potential for temporary, adverse health consequences.
Unfortunately, physicians and surgeons are often unaware (through no fault of their own) of the potentially harmful or deadly consequences of using certain devices on their patients. Our job is to hold manufacturers accountable for failing to run proper testing or otherwise being negligent in producing medical devices. The Ruth Law Team represents victims who have been injured by unsafe medical devices such as this. For more information on products liability cases, contact us at 1-888-783-8378.