DATE RECALL INITIATED:
Regeneration Technologies, Inc
Regeneration Technologies, Inc. (RTI) is conducting a voluntary recall of all tissue received from BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) as a result of information regarding the accuracy of donor screening documentation. RTI informed its consignees that a lack of assurance of donor identity as well as the risk of infectious diseases also exists. Consignees are asked to contact the manufacturer to arrange for product return.
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.