CDC is working to respond to tuberculosis (TB) disease cases associated with viable bone matrix material. The cases appear to be linked to a single product lot used in surgical and dental procedures. Shipments of this product lot were sent to seven states between February 27, 2023, and June 20, 2023.
The product manufacturer sent a voluntary recall notice for this product on July 13, 2023. All facilities and states involved have been contacted and all unused units of this product lot have been sequestered, meaning they have been removed from inventory and will not be used. CDC and FDA are working with state and local health departments, hospitals, surgical centers, and dental offices in the affected states to prevent further patient harm and determine if additional measures can be taken to prevent similar outbreaks in the future.
TB is caused by a bacterium called Mycobacterium tuberculosis (MTB) and can cause severe disease and death if untreated.
Recommendations Issued to Date Include:
- Healthcare providers should continue to work with their respective health department’s TB program to immediately contact patients who underwent surgery using ViBone or alloOss lot #TDS222820 for evaluation and treatment. CDC recommends that all patients who received these products (#TDS222820) begin treatment for TB disease, even if they do not have any symptoms. Treatment should be coordinated with infectious disease and TB experts. Healthcare providers can request medical consultation through the TB Centers of Excellence for Training, Education, and Medical Consultation.
- Hospitals and dental offices should work to identify any healthcare personnel who may have been exposed to Mycobacterium tuberculosis during patient surgery or during patient care.
- Healthcare providers should report adverse patient outcomes to FDA’s MedWatch Adverse Event Reporting program.
- Healthcare providers and facilities should also notify the manufacturer of adverse patient outcomes using the procedures detailed in the manufacturer’s communications.
Additional Information for Patients and Healthcare Providers
- For more information on TB visit: Tuberculosis (TB) | CDC
- For information on healthcare personnel isolation precautions for TB disease: CDC Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)(see Appendix A)
- For more information on the product recall: Aziyo Biologics Announces Voluntary Recall of Viable Bone Matrix Products | Aziyo Biologics, Inc.
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