FDA: Class I recall of Zimmer Biomet implantable spinal fusion stimulators

Editor's Note

The Food and Drug Administration (FDA) on May 30 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its SpF PLUS-Mini and SpF XL IIB implantable spinal fusion stimulators as Class I, the most serious.

The recall was initiated because of higher than allowed levels of potential harmful chemicals that were found during the company’s routine cytotoxicity monitoring of the device.

The stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine together. The device is implanted in the patient’s back and provides constant electrical stimulation to the surgical site.

Posted 05/30/2017] AUDIENCE: Risk Manager, Orthopedics, Patient, Surgery ISSUE: Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure.