Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators
SpF® PLUS-Mini (60μA/W) & SpF® SpF XL IIB Implantable Spinal Fusion Stimulators
The SpF® PLUS-Mini (60μA/W) & SpF® SpF XL IIB Implantable Spinal Fusion Stimulators are used by surgeons during spinal fusion surgery. The device is implanted in the patient’s back and provides constant electrical stimulation to the surgical site, which increases the possibility of successfully reconnecting two or more bones of the spine.
Class I Recall Issued April 20, 2017
On April 20, 2017, Zimmer Biomet sent Urgent Medical Device Removal notifications to all patients who have undergone spinal fusion procedures involving the recalled devices and to all healthcare providers using the devices. The notifications instruct health care providers to quarantine all recalled products for later removal by a Zimmer Biomet representative. Additionally, surgeons are instructed to postoperatively monitor any patient implanted with a recalled device for three to six months.
This is a Class I recall, the most serious type of recall, and applies to 33 device serial numbers distributed from March 28, 2017 to April 6, 2017. The devices were manufactured between October 11, 2016 and January 18, 2017.
Reason for Recall
A cytotoxicity test, which measures the compatibility of a device and the human body, found that the spinal fusion simulators contain potentially harmful chemicals at higher than allowed levels. The chemicals released can be toxic to tissues and organs in the human body.
- chronic infection
- long-term hospitalization due to additional surgical procedures
If you underwent spinal fusion surgery, please check with your surgeon to see if the device was used during your operation. If you or your loved one experienced any of the above injuries, you could be entitled to significant compensation.