Zimmer recalls Biomet spine stimulators because of poor validations

Zimmer Biomet recalls spine fusion, bone growth stimulators (MedTechDive)
Dive Brief:

Zimmer Biomet is recalling 1,360 of its implantable spine fusion and long bone stimulators in the United States, due to a lack of adequate validation and controls to ensure the final products were clean and free from bacteria and chemical residue, FDA said.
FDA categorized the recall as Class I, meaning the devices could lead to serious injuries or death. Three devices are affected: EBI Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini (60 μA/W) Implantable Spinal Fusion Stimulator, and SpF-XL IIb...