REGULATORY UPDATE: Urgent Voluntary Recall of Cellular Therapy Products After Potential Tuberculosis Transmission
June 09, 2021
The Food and Drug Administration announced an urgent voluntary notification
recalling FiberCel Fiber Viable Bone Matrix. Aziyo Biologics, Inc., the manufacturer of record, is voluntarily recalling a single lot, donor lot number NMDS210011. Aziyo is voluntarily recalling these products “out of an abundance of caution” based on a customer complaint from a hospital that reported post-surgical infections in 7 of the 23 patients receiving FiberCel from this donor lot. Four of these patients have tested positive for tuberculosis.
Aziyo issued an Urgent Notification Letter on June 2 that instructed customers who received FiberCel product from this single donor lot to immediately examine their inventory and quarantine any remaining product. FDA’s announcement instructs Aziyo customers who have further distributed FiberCel product from this donor lot to “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.” FiberCel customer complaints should be reported to Medtronic at 888-869-2435.