Zimmer Biomet Recalls 1,360 Spinal Fusion and Long Bone Stimulators Over Risk of Contamination
The devices have been identified by the FDA under a Class I recall, the most serious type of recall reserved for products or devices that may cause serious injuries or death.
Zimmer’s implantable bone growth and spinal fusion stimulators are used to help heal broken long bones in the arms and legs or bone following spinal fusion surgery. The stimulators are implanted during surgery, primarily in individuals who have a health condition or whose bodies have difficulty healing bone on its own.
Here are the Zimmer devices identified under the recall:
· SpF-XL Implantable Spinal Fusion Stimulator
· SpF PLUS-Mini Implantable Fusion Stimulator
· Osteogen Implantable Bone Growth Stimulator
All of the devices were manufactured between February 14, 2015 and April 11, 2017 and would’ve been distributed between April 29, 2015 and March 31, 2018. The number of devices recalled totals 1,360 units in the U.S.
About the recall
The devices were recalled due to a “lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue,” according to the FDA.
Side effects caused by these inadequacies include infection, swelling around the spinal cord, damage to other organs, tissue death, the need for additional surgeries, impaired wound and bone healing, paralysis, or death.
If you or a loved one were implanted with any of these stimulators after spinal fusion surgery or to help heal long bones and have suffered a severe side effect, contact us today.