Zimmer Biomet recalled 1,360 spinal fusion and long bone stimulators due to a lack of adequate validation and controls to ensure product cleanliness. The FDA has identified this as a Class I recall, making it the most serious type of medical device recall.
The company is recalling the Osteogen implantable bone growth stimulator, the SpF PLUS-Mini implantable fusion stimulator, and the SpF-XL implantable spinal fusion stimulator. All serial numbers expiring prior to 31 March, 2019 are affected.
The Zimmer implantable bone growth and spinal fusion stimulators are used to help heal bone following spinal fusion surgery or to help heal broken long bones (those of legs or arms) in people who have a health condition or other factors that prevent their body from healing bone on its own. These stimulators are placed in a patient during surgery. Once in place they send a low level electrical signal to encourage the body’s natural bone healing process.
Zimmer Biomet is recalling these devices 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.
Those who may be affected include health care providers who use the EBI Osteogen implantable bone growth stimulator, SpF PLUS-Mini implantable spinal fusion stimulator or SpF XL IIb 2/DM implantable spinal fusion stimulator, as well as patients who have been implanted with any of these stimulators after spinal fusion surgery or to help heal long bones.