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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Tendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA CL1202013007; CL1202013008; CL1202013009; CL1202013010; CL1202013003 Class I Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. 5 B-0163-13
Bone, Human Tissue allograft; CeSpace (Brand for Aesculap, Inc.); Prepared by Aesculap, Inc., Center Valley, PA and distributed by TBI National Processing Center, San Rafael, CA CL1202013057; CL1202013061; CL1202013064; CL1202013068; CL1202013071; CL1202013075; CL1202013079; CL1202013084; CL1202013077; CL1202013083; CL1202013056; CL1202013058; CL1202013059; CL1202013060; CL1202013062; CL1202013063; CL1202013065; CL1202013066; CL1202013067; CL1202013069; CL1202013070; CL1202013072; CL1202013073; CL1202013074; CL1202013076; CL1202013078; CL1202013080; CL1202013081; CL1202013082; CL1202013085; CL1202013086; CL1202013006; CL1202013004 Class I Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. 33 B-0162-13
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