Voluntary Market Withdrawal Satisfied
This update is to provide Final Notification about Bacterin’s August 2011 Voluntary Market Withdrawal (which was classified as a Class III recall per the FDA on August 8, 2012). This matter has been resolved with the FDA and an exemption request has been granted that allows Bacterin International, Inc. the opportunity to consider the donors listed in the below documents for release to distribution. It should be noted that the release of these allografts is deemed by the FDA to pose no additional risk of disease transmission.
We want to thank our customers for working with us throughout this process and for their continued support. Bacterin remains committed to providing safe and effective allografts for the clinical needs of surgeons and their patients and are pleased with the FDA’s final resolution. Please review the documents below for additional information; this Voluntary Market Withdrawal has been resolved.