In the last two years, six major spine and orthopedic devicemakers have had to recall products for an array of reasons, from tuberculosis concerns to faulty joint implants.
Several devicemakers are facing ongoing lawsuits and recurrent recalls:
1. Aziyo Biologics recalled its viable bone matrix products after two patients were infected with Mycobacterium tuberculosis following surgeries. Two years ago, Aziyo Biologics recalled another bone repair product, FiberCel, after multiple patients tested positive for tuberculosis.
2. The FDA issued a Class I recall of Abbott Medical's implantable Abbott Proclaim neurostimulation systems, designed to deliver low-intensity electrical impulses to nerve structures for spinal cord stimulation. The recall was initiated after patients complained of an inability to exit MRI mode. The patient controller (iPhone/iPod) may lose the ability to connect or communicate with the device while in MRI mode.
3. On Jan. 6, 2022, Medtronic issued a Class I recall of the company's Synergy Cranial and StealthStation S7 Cranial software. The StealthStation system with the Synergy Cranial and StealthStation S7 Cranial software was also recalled in January 2019.
4. In August of 2022, Exactech recalled 40,000 implants. Now, the devicemaker is facing hundreds of lawsuits filed on behalf of 1,100 patients who say they received faulty joint implants.
5. In 2021, Zimmer Biomet recalled its Rosa One 3.1 brain application because of a software error that could lead to the misplacement of instruments during neurosurgical procedures.
6. In 2021, Aziyo Biologics voluntarily recalled a lot of its FiberCel product out of an abundance of caution after a customer complaint from one hospital that initially reported postsurgical infection in seven of the 23 patients who received FiberCel from the donor lot. Four of those patients tested positive for tuberculosis.