Zimmer Biomet® has announced it is recalling its SpF PLUS-Mini® and SpF XL IIB® implantable spinal fusion stimulators due to higher than allowed levels of harmful chemicals that may be toxic and deadly to tissues and organs. The FDA has indicated that the use of the affected products may cause serious adverse health consequences that include, but are not limited to, chronic infections, additional surgery(ies), hospitalization, paralysis, and even death in some cases.
The affected products were used during spinal fusion surgeries between March 28, 2017, and April 6, 2017. The devices are used during spinal fusion surgery to increase the likelihood that the fused spinal bones will permanently connect to each other. The device is implanted into the patient’s back and provides electrical stimulation to the spine at the site of the surgical fusion.
Patients and affected consumers are to receive a notice advising them to follow up with their doctor and/or surgeon, and that patients should be clinically monitored closely during the 3-6 month period following surgery involving an affected implant device.
If you, a family member, or a friend have recently undergone spine surgery and received a fusion stimulator during your surgery please do not hesitate the experienced lawyers at Strong Law Offices to discuss the recall in more detail, and how this device may affect you. Strong Law Offices is currently investigating potential claims on behalf of patients who have been adversely affected by this device.