Infections and Tuberculosis Caused Recall of Bone Repair Product
Reports Bone Repair Product Associated with Infections and Tuberculosis
Aziyo Biologics Inc., recalled some of its FiberCel bone repair product. The product contains human tissue. The intent of the bone cement is to help repair bones and facilitate healing.
Some patients received the product during orthopedic and spinal procedures. Some reported suffering post-surgical infections, including tuberculosis. This voluntary recall affects one lot of 154 units of the product, all of which were obtained from a single donor and shipped to medical facilities in 20 different states, including Maryland. The recall likely impacts about 100 people.
FDA Announces Recall of the FiberCel Fiber Viable Bone Matrix (“FiberCel”)
FDA published a urgent voluntary notification concerning the manufacturer of the FiberCel Fiber Viable Bone Matrix (“FiberCel”) product. Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”). It is voluntarily recalling one Lot of the bone cement, FiberCel product, Donor Lot Number: NMDS210011. The company issued this voluntary recall out of an abundance of caution following a customer complaint from one hospital that initially reported post-surgical infection in 7 of the 23 patients that have received FiberCel from this Donor Lot. Four of these patients have tested positive for Tuberculosis.
From the FDA notification, it “instructs any customer who received FiberCel product from this single Donor Lot to immediately examine its inventory and quarantine any remaining product. If you further distributed FiberCel product from this Donor Lot elsewhere, please identify your customers and notify them at once of this request to immediately quarantine and return any remaining product. Aziyo will provide prepaid shipping containers for the return of any unused FiberCel product from this Donor Lot.” Call Medtronic with complaints or concerns at 888-869-2435.
If you had an infection and tuberculosis after orthopedic and spinal procedures, ask your physician if you had FiberCel Fiber Viable Bone Matrix, and if so, obtain medical advice. If you want to explore your legal options, please contact KBA to discuss further.