November 28, 2018

FDA: Class I recall of Zimmer Biomet spinal fusion, long bone stimulators

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on November 26 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and SpF-XL Implantable Spinal Fusion Stimulator as Class I, the most serious.

The recall was initiated because of the lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue. The lack of validation and controls may cause serious side effect including infection, paralysis, organ damage, and death.

The recall includes all serial numbers expiring before March 31, 2019.

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