Zimmer Biomet Spinal Fusion Stimulator Recall: Harmful Chemicals

A recall has been issued for certain Zimmer Biomet devices used for spinal fusion surgery, due to a risk that they may contain high levels of potentially harmful chemicals that may be toxic to patients. 

The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulator recall was announced by the FDA on May 30, indicating that the chemicals in the devices could result in severe injury or death to patients. The agency has classified the recall as Class I, the most serious recall classification.

The Zimmer Biomet spinal fusion stimulators are used to increase the likelihood of two or more bones of the spine fusing together. The device is implanted into the patient’s back, providing constant electrical stimulation to the surgical site.

According to an Urgent Medical Device Removal notification issued by Zimmer Biomet on April 20, the devices are being recalled due to a “higher than allowed levels of potential harmful chemicals.” The chemicals may be toxic to tissues and organs. The high chemical levels were discovered during a routine monitoring procedure by the company. The chemicals could cause chronic infections, long-term hospitalization, paralysis and death.

The recall affects SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators distributed from March 28, 2017 to April 6, 2017, and manufactured between October 11, 2016 to January 18, 2017. Serial numbers for affected SpF-PLUS devices include 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, and 410171; and serial numbers for affected SpF-XL IIB include 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, and 224667. There were 33 of the devices sold in the U.S.

Zimmer has called on its customers to distribute the warnings about the devices to all appropriate personnel, and to quarantine all affected products. It’s sales representatives will remove the products from the facilities.

“Surgeons are reminded that normal clinical monitoring is recommended for 3-6 months post operatively for any patient with the affected devices implanted,” the recall warning notes.

Customers with questions can contact Zimmer Biomet at 1-800-447-3625, or by e-mail at corporatequality.postmarket@zimmerbiomet.com.