STORY FROM: Drugs & Medical Devices
Zimmer Recalls Implantable Spinal Fusion Stimulators, Citing High Levels of Harmful Chemicals
June 1, 2017
WASHINGTON, D.C. — Zimmer Biomet is recalling its SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to high levels of potential harmful chemicals, which may be toxic to tissues and organs, according to a recent Food and Drug Administration announcement.
In a May 30 MedWatch alert, the FDA explained that Zimmer found higher than allowed levels of the chemicals during a routine monitoring procedure. Use of the affected devices could cause serious adverse health problems, including chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death, the FDA says.
The SpF PLUS-Mini and SpF XL ...