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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Product Detail

Product Description Tendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA
Recall Number B-0163-13
Classification Class I
Code Info CL1202013007; CL1202013008; CL1202013009; CL1202013010; CL1202013003
Product Distributed Qty 5
Reason For Recall Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.

Event Detail

Event Id 63120
Product Type Biologics
Status Terminated
Recalling Firm Tissue Banks International
City San Rafael
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-31
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Allograft products were released for distribution to 6 consignees in US. located in CA, MD and PA.