Zimmer Biomet recalls bone stimulators on contamination risk

Zimmer Biomet (NYSE:ZBH) recalled nearly 1,400 bone stimulators on the risk that they could be contaminated with bacteria or chemicals, the FDA said yesterday. The Class I recall, denoting the risk of serious injury or death, covers 1,360 implantable bone growth and spinal fusion stimulators made and distributed between February 2015 and March 2018, including Zimmer Biomet’s Osteogen, SpF Plus-Mini and SpF-XL stimulators, the federal safety watchdog said. The devices are designed to stimulate healing after spinal fusion procedures or long-bone breaks. The voluntary recall was launched Feb. 19 “due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue,” the FDA said. “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 (epidural abscess), paralysis, damage to other organs or death,” the agency warned. It’s the latest regulatory stumble for Warsaw, Ind.-based Zimmer Biomet, which received a warning letter from the FDA last summer over quality violations found during 2016 and 2018 inspections there. The FDA inspected the North Campus facility in Warsaw jus...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Orthopedics Recalls Regulatory/Compliance Spinal Zimmer Biomet Source Type: news