Regeneration Technologies, Inc. Issues Voluntary Recall of Certain TissueOct 14, 2005 | PR Newswire Regeneration Technologies, Inc. (RTI) (Nasdaq: RTIX ), the Florida-based processor of orthopedic, cardiovascular and other biologic implants, announced today that the company, working with the Food and Drug Administration (FDA), has issued a voluntary recall.
The recall consists of allograft implants processed from donor tissue received from Biomedical Tissue Services (BTS), an unaffiliated donor recovery organization, due to questions raised with respect to donor documentation received from that organization. RTI has tissue recovery relationships with more than 300 other organizations that are not affected by this recall.
"In the past weeks, RTI terminated its relationship with BTS and had begun quarantine and market withdrawal processes for the affected tissue. Although RTI tissue preparation processes are validated to further ensure the safety of the tissue, we feel that it is best to act with an abundance of caution," said Brian K. Hutchison, chairman, president and CEO. "We continue to cooperate with the appropriate authorities on this issue."
The company is still assessing the impact of the recall and estimates a potential charge to operating income of approximately $3.0 million on third quarter results. The charge consists of write-downs of tissue inventories of $1.7 million and replacement of distributor inventories of approximately $1.3 million.