FiberCel Bone Matrix Recall, Warning Issued After Infection Reports
Reports of post-surgical infections have been linked to FiberCel Bone Matrix tissue products, including some cases involving patients who tested positive for tuberculosis, leading the manufacturer to recall one donor lot of the biologic product made from human tissue.
The FDA announced the FiberCel Fiber Viable Bone Matrix recall on June 2, impacting 154 units used during spine and orthopedic procedures, which were all derived from a single donor and shipped to facilities in 20 states.
The recall was issued after customers from one hospital reported post-surgical infections from FiberCel Bone Matrix among seven of the 23 patients who received units from this donor lot. Additionally, four of the patients tested positive for tuberculosis.
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FiberCel is a fiber-based bone repair product, which is engineered to maintain characteristics of natural tissue for bone grafts or alone as a bone void filler, and contains preserved living cells to facilitate bone repair and healing.
Tuberculosis is caused by the Mycobacterium tuberculosis bacteria and is a communicable disease. The infections are of such concern they need to be reported to the local or state health department tuberculosis program. It can be treated with a combination of antibiotics.
The affected FiberCel products include product numbers VBM9901, VBM9905, and VBM9910 from lot number NMDS210011.
Aziyo Biologics, Inc., the manufacturer, suspended sales of FiberCel until further notice out of caution for its customers. Aziyo also issued an Urgent Notification Letter on June 2 to hospitals that received the product from the affected lot. The notification instructs customers who received FiberCel from this donor lot to examine its inventory and quarantine any remaining product.
If necessary, hospitals should identify their customers and notify them at once of the recall and quarantine any remaining product and return it to the company. Aziyo will provide prepaid shipping containers for the return of any unused FiberCel.
Complaints associated with the FiberCel product recall should be directed to Medtronic by calling 888-869-2435.
Side effects linked to the recalled FiberCel bone products should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
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