Some Zimmer Biomet bone growth and spinal fusion simulators are being recalled because the manufacturer and regulators cannot be certain the devices are free from bacteria and chemical residue, which could increase the risk of injury or death for patients.
The Zimmer Biomet SpF bone stimulator recall was announced by the FDA on November 26, due to contamination concerns. To date, no deaths or serious injuries have been reported in relation to the recall.
The bone growth and spinal fusion stimulators are implanted to help heal broken bones in patients receiving spinal fusion surgery, or to assist in the recovery of long broken bones in the arms or legs of patients who are unable to heal on their own. Once the devices are implanted, a low level electrical signal encourages the body’s natural bone healing process.
According to the recall, the manufacturer became aware that several models of it bone and growth simulators were not properly validated and control measures to clear bacteria chemical residue were not in place. The lack of these process poses an risk to patients, who could have contaminated devices implanted in their body.
FDA officials warn patients could be at risk of a wide variety of side effects, including infection, tissue death, additional surgery for wound treatment 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, paralysis, damage to other organs or death.
The recall includes the EBI Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini (60 μA/W) Implantable Spinal Fusion Stimulator or SpF-XL IIb 2/DM Implantable Spinal Fusion Stimulator. The devices were manufactured by Zimmer Biomet, Inc. of Warsaw, Indiana from February 12, 2015 through April 11, 2017 and distributed to licensed medical facilities from April 29, 2015 to March 31, 2018.
Zimmer first recognized the issue in February 2018 and issued an Urgent Medical Device Recall Notification Letter to all affected customers instructing hospital risk managers to set aside all impacted devices and schedule a return to the manufacturer.
Surgeons are instructed to discontinue using the affected devices and to closely monitor patients who have one of the recalled devices implanted for infection or abnormalities.
FDA officials have designated the company’s actions as a Class I recall, indicating the agency believes the use of the impacted devices could result in serious injury or death.
Customers with additional questions or concerns regarding the recall are encouraged to contact Zimmer Biomet at 574-371-3071 or email them at firstname.lastname@example.org.