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 2/DM Implantable Spinal Fusion Stimulator.
Zimmer Biomet sent an Urgent Medical Device Recall Notification Letter to all affected customers on Feb. 19, 2018.
Dive Insight:
The recall is a setback for a company that has been mounting a turnaround bid under new CEO Bryan Hanson, hired in December from Medtronic. The company last month posted a 64% rise in third-quarter profit. Hanson has been on a mission to improve the performance of the orthopaedic implant maker after former CEO David Dvorak struggled to integrate Zimmer’s $13.35 billion acquisition of cross-town rival Biomet.
But in August, F...
