STORY FROM: Drugs & Medical Devices

Zimmer Recalls Implantable Spinal Fusion Stimulators, Citing High Levels of Harmful Chemicals

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 ...



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