A recall of bone growth and spinal fusion stimulators initiated by Zimmer Biomet in February was identified Tuesday by the Food and Drug Administration as a Class I recall, the most serious type of medical device recall, according to several trade publications.
A total of 1,360 implantable devices, used to either help heal bone after spinal fusion surgery or to help heal broken long bones such as an arm or leg, are on the recall list.
Specifically, the recalled product is the company’s Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini Implantable Fusion Stimulator, and the SpF-XL Implantable Spinal Fusion Stimulator. All serial numbers expiring before March 31, 2019, are affected, FDA said. The affected products were distributed between April 29, 2015 and March 31 of this year.
An article on the Medical Device and Diagnostic Industry website (mddionline.com) indirectly quotes an FDA spokesperson as saying “Zimmer Biomet initiated the recall because of a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.
“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.”
Zimmer Biomet has asked unused products be returned and instructed surgeons to continue monitoring patients in whom the devices have already been implanted.
The FDA has visited the Zimmer Biomet campus multiple times in recent years and documented several instances where inspectors have had issues with the company’s packing processes. The MD+DI article also said “Zimmer Biomet has struggled with quality control and supply chain problems since December 2016, which has created investor frustration that ultimately led to former CEO David Dvorak’s resignation last July. Earlier this year, MD+DI identified five reasons Zimmer Biomet could make a comeback under new CEO Bryan Hanson’s leadership.
“FDA re-inspected Zimmer Biomet’s Warsaw North Campus facility in April, which resulted in a warning letter from the agency. The company said some of the agency’s recent findings might have been a byproduct of misunderstandings or disagreements between company personnel and FDA investigators.
“During Zimmer Biomet’s third-quarter earnings call, Hanson said the company is making progress toward its supply recovery goals, but he is still not happy with the current state of the supply chain.
“Hanson also said during the late October call that Zimmer Biomet must start reducing the size of its portfolio in order to simplify the supply chain and improve service levels to customers.”
