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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
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