DATE NOTIFICATION INITIATED:

June 2, 2021

PRODUCT / LOT NUMBER:

FiberCel Fiber Viable Bone Matrix (“FiberCel”)
Product Numbers: VBM9901, VBM9905, VBM9910
Lot Number: NMDS210011

MANUFACTURER:

Aziyo Biologics, Inc.
Richmond, CA

REASON:

Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product, Donor Lot Number: NMDS210011. This voluntary recall is being issued 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.

Aziyo issued an Urgent Notification Letter on June 2, 2021. This notification 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. Any complaints associated with FiberCel should be directed to Medtronic by calling 888-869-2435.

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The information in this listing reflects CBER’s best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.