Aziyo Biologics, a regenerative medicine company, voluntarily recalled a lot of its FiberCel product after several patients who received it tested positive for tuberculosis, according to the FDA.
The lot of bone repair product was recalled June 2, after seven of 23 patients who received the product at a single hospital reported postoperative infections, and four tested positive for tuberculosis. The infected lot, No. NMDS210011, included 154 units of FiberCel from a single donor. The lot was distributed to facilities in 20 states, according to a June 7 statement from the company.
Aziyo recommended patients who received the product from the infected lot quarantine immediately while it recovers unused units. The company said it doesn't believe any other FiberCel units are infected, but it has paused the product's sale.
FiberCel is a bone matrix allograft to promote bone repair in orthopedic and spine procedures. Medtronic, a global medtech company, distributes FiberCel in the U.S.