Zimmer recalls Biomet spine stimulators because of poor validations
- Zimmer Biomet is recalling 1,360 of its implantable spine fusion and long bone stimulators in the United States, due to a lack of adequate validation and controls to ensure the final products were clean and free from bacteria and chemical residue, FDA said.
- FDA categorized the recall as Class I, meaning the devices could lead to serious injuries or death. Three devices are affected: EBI Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini (60 μA/W) Implantable Spinal Fusion Stimulator, and SpF-XL IIb 2/DM Implantable Spinal Fusion Stimulator.
- Zimmer Biomet sent an Urgent Medical Device Recall Notification Letter to all affected customers on Feb. 19, 2018.
The recall is a setback for a company that has been mounting a turnaround bid under new CEO Bryan Hanson, hired in December from Medtronic. The company last month posted a 64% rise in third-quarter profit. Hanson has been on a mission to improve the performance of the orthopaedic implant maker after former CEO David Dvorak struggled to integrate Zimmer’s $13.35 billion acquisition of cross-town rival Biomet.
But in August, FDA issued a warning letter to Zimmer Biomet for violations of good manufacturing practices at its Warsaw, Indiana, north campus plant. The plant was acquired in the 2015 Biomet purchase.
The three implantable stimulators being recalled are legacy Biomet products. The recall appears to be an expansion of a 2017 recall involving a smaller number of Zimmer Biomet SpF PLUS-Mini (60μA/W) and SpF-XL IIB implantable spinal fusion stimulators due to higher than allowed levels of potentially harmful chemicals.
The implantable bone growth and spinal fusion stimulators are used to help heal bone in patients who have had spinal fusion surgery or in those with broken long bones in the arms or legs who have a health condition or other factors keeping the bone from healing on its own.
The stimulators are implanted during surgery and send a low-level electrical signal to encourage the body’s natural bone healing process.
FDA said the company is recalling the devices because the lack of adequate validation and controls to ensure product cleanliness could cause serious side effects in patients. The agency identified the potential for 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.
Zimmer Biomet’s Feb. 19, 2018 recall notification letter to customers instructed surgeons to monitor patients who have one of the affected devices implanted, FDA said. Hospital risk managers are advised to set aside any product for sales representatives or distributors to pick up, and distributors are advised to quarantine any devices in inventory and send them back to the company.
The devices were manufactured between Feb. 14, 2015 and April 11, 2017 and distributed from April 29, 2015 to March 31, 2018. All serial numbers expiring before March 31, 2019 are affected.