May 31, 2017
Zimmer Biomet announced a recall of the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators, according to a release from the FDA.
The devices are used during spinal fusion surgery to decrease the possibility of permanently connecting two or more bones of the spine together. The release noted that Zimmer Biomet has found higher than allowed levels of potential harmful chemicals, which may cause cytotoxicity, during a routine monitoring procedure. According to the release, use of the product may cause chronic infections, long-term hospitalization due to additional surgical procedures, paralysis and death, among other serious adverse health consequences.