Regeneration Technologies Inc., processor of orthopaedic, cardiovascular and other biologic implants, which is working with the FDA, has issued a voluntary recall of allograft implants processed from donor tissue received from Biomedical Tissue Services (BTS), an unaffiliated donor recovery organisation, due to questions raised with respect to donor documentation received from that organisation. RTI has tissue recovery relationships with more than 300 other organisations 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. We continue to cooperate with the appropriate authorities on this issue," said Brian K. Hutchison, chairman, president and CEO, RTI.

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, claims a company release.

According to the company release, RTI takes every precaution available to ensure the safety of the patients receiving its processed tissue. Donors and tissue received from any source are subjected to rigorous laboratory testing using the latest techniques. Only that tissue meeting stringent acceptance criteria is utilised for processing. Tissue processing further reduces inherent risk by exposing the tissue to one or more validated processes for viral inactivation and sterilisation.

RTI processes allograft and xenograft tissue into shaped implants for use in orthopaedic, cardiovascular and other surgeries with a commitment to science, safety and innovation.