Proven Record of Safety

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Tissue Safety

RTI is committed to providing safe, high quality allografts for surgeons and their patients. We believe that the more you know about RTI Surgical, the more confident you will be in the safety of our tissue implants.

FDA Warning Letter Close Out - 10/29/13

FDA Warning Letter Update - 9/11/13

Update on FDA Warning Letter – 1/16/13

Summary of actions taken by RTI – 12/20/12

A statement from the CEO regarding tissue safety – 12/14/12

The safety of any tissue is contingent upon three stages – donor screening, laboratory testing and tissue preparation validated to address potential disease transmission.

For surgeries involving tissue implants, RTI has developed methodologies to address the risk of infection that could be caused by the implants themselves. Where possible, we use validated, proprietary sterilization processes – such as BioCleanse®, Tutoplast® and Cancelle™ SP – to provide safe tissue implants that have changed the lives of patients around the world.

We have provided more than four million implants with zero incidence of implant-associated infection. At RTI, that’s our track record, and we’re proud of it.

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Tissue Definitions

Allograft Tissue
Tissue (bone, tendons, ligaments, skin, heart valves) taken from one person for transplantation into another.
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Xenograft Tissue
Animal-derived tissue (bovine or porcine) that is transplanted to a human recipient.
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