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 just before Thanksgiving 2016, documenting numerous violations in a Form 483 m notification. The company’s lengthy reply that December detailed its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site. Zimmer said it cleaned house after the inspection, replacing five operations and quality executives as it sought to bring the facility back into compliance.
But a re-inspection last April resulted in another Form 483 and then the warning letter flagging “continuing, significant violations of the quality system regulations” found during the April 2018 inspections, including failure to show that its process for corrective and preventive actions can ensure that the plant meets finished product specifications and the lack of adequate training procedures. The inspectors also found problems with the North Campus facility’s design validation processes, its handling of non-conformance reports and its CAPA implementation, according to the warning letter.
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