Zimmer Biomet initiated a recall of 1,360 units of the Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator and SpF-XL Implantable Spinal Fusion Stimulator devices.
The Class I recall was implemented due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue. The devices were manufactured from February 14, 2015 to April 11, 2017, and all serial numbers expiring before March 31, 2019 are affected.
These devices are designed to assist in the healing of bone following spinal fusion or to help heal broken long bones, and are placed in a patient during surgery. Once in place, they send a low level electrical signal to support the body's natural bone healing process.