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Voluntary Tissue Recall
 



Voluntary Tissue Recall Resource Center

Medtronic wants to make sure you have access to the latest information regarding the Regeneration Technologies Inc. (RTI) voluntary recall of specific lots of tissue used for spinal surgery.

This site lists all tissue identification numbers (TID numbers) of allografts distributed by SpinalGraft Technologies, LLC (SGT), that have been recalled by Regeneration Technologies, Inc. (RTI), in cooperation with the FDA. According to information provided to SGT by RTI, the attached list represents all allografts distributed by SGT that were processed from donors provided to RTI by Biomedical Tissue Services (BTS). The list is provided for the use of health care professionals who want to verify whether a particular allograft distributed by SGT is subject to the recall.

DISCLAIMER: This list is not an exhaustive list of all allografts that have been recalled. This list only contains TID numbers of allografts distributed by SGT that are subject to the recall. You may have received recalled allografts distributed by other companies. The attached list does not contain TID numbers of recalled allografts processed by companies other than RTI, or of recalled RTI allografts distributed by other entities. Other processors that have recalled allografts related to BTS are: LifeCell Corporation (Branchburg, N.J.); Tutogen Medical, Inc. (Alachua, FL); Lost Mountain Tissue Bank (Kennesaw, Georgia); and the Blood and Tissue Center of Central Texas (Austin, Texas). All of these processors are conducting recalls of allografts processed from tissue donated by BTS. In addition, each processor may have multiple distribution channels. If you are a hospital that is attempting to determine whether it received or has any recalled tissue, you should contact each of the affected processors directly.

For Patients For Physicians
Patient Q & A

Information You Should Know

Information regarding Donor Referral Services
RTI Redundancy Safeguards
RTI Biocleanse Fact Sheet
FDA Press Release
FDA Orders Biomedical Tissue Services to Cease Manufacturing
NY DA Charges
FDA updates BTS tissue
Important patient testing guidelines from the CDC

Toll-free Hotline

You can call 866-825-6158 Monday through Thursday 7 a.m. – 7 p.m. CST and 7 a.m. – 6 p.m. CST on Friday to talk with a registered nurse who can answer your questions about medical issues, testing information and follow-up treatment.

Media Statement

Link to RTI's Website

Recalled Lot Numbers

Patient Testing Program

We are making available a Patient Testing Program for patients who received tissue subject to the recall from Regeneration Technologies, Inc. (RTI). Medtronic has arranged for Laboratory Corporation of America (LabCorp) and Quest Diagnostics, nationally recognized CLIA certified reference laboratories, to assist with testing needs. Under this arrangement, these laboratories will bill Medtronic directly for the testing. Patients will not incur any out-of-pocket costs for this testing. Click here for Instructions for Blood Testing.

LabCorp Form
    www.labcorp.com

Quest Sample Form
    www.questdiagnostics.com




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