Tutogen Medical Inc. Issues Voluntary Product Recall

WEST PATERSON, N.J., Oct. 13 /PRNewswire-FirstCall/ -- Tutogen Medical, Inc. , a leading manufacturer of sterile biological implant products made from human (allograft) and animal (xenograft) tissue, announced that on October 12, 2005 the Company issued a voluntary recall of all product units which utilized donor tissue received from BioMedical Tissue Services/BioTissue Recovery Services (BioMedical). This action was taken because the Company was unable to satisfactorily confirm that donor consent had been properly obtained by BioMedical. The Company has quarantined all BioMedical product in its inventory and is in the process of notifying all customers and distributors of record, regarding this action. The Company is still assessing the impact of the recall on fourth quarter results and estimates a potential charge to operating income of approximately $1 to $1.5 million.

Guy Mayer, Chief Executive Officer for Tutogen Medical, Inc., said, "Although we are confident that our products are of the highest quality and safety, we have elected to voluntarily recall all materials that were manufactured utilizing BioMedical donor tissue, which represents only about two percent of our manufactured products. Since donor approval is in question, we do not wish to ethically conflict with our customers or our business partners. Additionally, we are working closely with the FDA, our customers and our distribution partners throughout this voluntary recall process, as patient safety and product quality is of the utmost importance."

The Company's Tutoplast process has been shown to be highly effective in the inactivation of conventional and unconventional viruses and prions and in the prevention of disease transmission. The Tutoplast process has been in use for more than 30 years-representing more than one million products implanted-without a single documented case of disease transmission.

About Tutogen Medical, Inc.

Tutogen Medical, Inc. manufactures sterile biological implant products made from human (allograft) and animal (xenograft) tissue. Tutogen utilizes its Tutoplast Process(R) of tissue preservation and viral inactivation to manufacture and deliver sterile bio-implants used in spinal/trauma, urology, dental, ophthalmology, and general surgery procedures. The Company's Tutoplast(R) products are sold and distributed worldwide by Zimmer Spine and Zimmer Dental, subsidiaries of Zimmer Holdings, Inc. the Mentor Corporation, IOP, Inc. and through independent distributors and subsidiaries in the U.S. and Germany. For more information, visit the Company's Web site at http://www.tutogen.com.

Forward Looking Statement Disclaimer: Certain statements in this news release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties, which may differ materially from those set forth in these statements. In addition, the economic, competitive, governmental, technological and other factors identified in the Company's filings with the Securities and Exchange Commission could affect such results.

Contacts: George Lombardi, Chief Financial Officer Tutogen Medical, Inc. 973-785-0004, ext. 101 glombardi@tutogen.com The RCG Group Joe Diaz, Robert Blum and Joe Dorame 480-675-0400

CONTACT: George Lombardi, Chief Financial Officer of Tutogen Medical,Inc., +1-973-785-0004, ext. 101, glombardi@tutogen.com; or Joe Diaz, RobertBlum, or Joe Dorame, all of The RCG Group, +1-480-675-0400, for TutogenMedical, Inc.

Web site: http://www.tutogen.com/