Zimmer Biomet has recalled 1,360 of its bone growth and spinal fusion stimulators due to a lack of adequate validation and controls to ensure that the final products did not contain bacteria and chemical residue. The implantable stimulators are typically placed in patients during surgery to help heal broken long bones or to accelerate the healing process following spinal fusion surgery—a type of surgery where two or more vertebrae are fused together so that they may heal into a single, solid bone. Once in place, the stimulators send a low-level electrical signal to encourage the body’s natural bone healing process.
The FDA has classed the recall as a Class I due to concerns about the adverse health consequences that the products may have caused patients. This includes serious side effects such as infections, tissue death, additional surgery for wound treatment and/or device removal, impaired wound and bone healing, the need for long-term antibiotic therapy, swelling and infection around the spinal cord, paralysis, and damage to other organs or death.
The recalled products include the EBI Osteogen implantable bone growth stimulator, the SpF PLUS-Mini, and the SpF-XL implantable spinal fusion stimulators. All serial numbers expiring before March 31, 2019 are affected. Zimmer Biomet’s recall notification letter to customers instructed surgeons to monitor patients who had one of the affected devices implanted. Hospital risk managers were advised to set aside the products so they could be retrieved, quarantined, and sent back to the company.
This is not the first time Zimmer Biomet has initiated a product recall. The company has previously struggled with quality control and supply chain problems. In 2016, Zimmer Biomet recalled its Comprehensive Reverse Shoulder, a shoulder replacement device that is surgically implanted to help restore arm movement. The company’s new Chief Executive Officer, Bryan Hanson, is on a mission to manage these setbacks and improve the performance of the orthopedic implants.