WARSAW — The FDA issued a Class I Recall of spinal fusion and long bone stimulators produced by Zimmer Biomet. The FDA identifies a Class I Recall as the most serious type of recall. Use of these devices may cause serious injuries or death. This recall applies to 1,360 implantable devices.
A recall letter was sent to all affected customers on Feb. 19. But the FDA identified the recall as a Class I Recall on Tuesday, Nov. 27. The specific implants affected include the EBI Osteogen Implantable Bone Growth Stimulator, the SpF® PLUS-Mini (60 μA/W) Implantable Spinal Fusion Stimulator or the SpF®-XL IIb 2/DM Implantable Spinal Fusion Stimulator.
The devices were manufactured between Feb. 14, 2015, and April 11, 2017, and distributed from April 29, 2015, to March 31, 2018.
The FDA explains that the recall is due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue. The lack of adequate validation and controls may or may not cause serious side effects for the patient including infection, tissue death, additional surgery for wound treatment and/or device removal, impaired wound and bone healing, the need for long-term antibiotic therapy, the potential for secondary gastroenteritis, swelling and infection around the spinal cord, paralysis, damage to other organs or death.
The implantable bone growth and spinal fusion stimulators are used to help heal bone following spinal fusion surgery or to help heal broken long bones in people who have a health condition or other factors that prevent their body from healing bone on its own.