Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | Mineralized Bone is labeled in part: "***Processed by: TissueNet***7022 TPC Dr Ste 400***Orlando, FL 32822***Sterilized By: T106^(r) {SAL 10-6}***Tissue ID:***Description: Mineralized Bone***Size 5cc***Product Code MB50050***Expiration***Freeze Dried: Store at 10 C - 37 C***Donated Human Tissue Allograft***Single Patient Use Only***". Full Product Description: Mineralized Bone .125-.85mm 5cc |
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| Recall Number | B-1642-12 |
| Classification | Class II |
| Code Info | Product ID: TN4211610153, TN4211610154, TN4211610155, TN4211610156, TN4211610158, TN4211610159, TN4211610160, TN4211610161, TN4211610162, TN4211610163, TN4211610164, TN4211610165, TN4211610166, TN4211610167, TN4211610168, TN4211610169, TN4211610170, TN4211610171, TN4211610172, TN4211610173, TN4211610174, TN4211610175, TN4211610176, TN4211610177, TN4211610178, TN4211610179, TN4211610180 |
| Product Distributed Qty | 27 ea |
| Reason For Recall | Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed. |
Event Detail
| Event Id | 60076 |
|---|---|
| Product Type | Biologics |
| Status | Ongoing |
| Recalling Firm | Surgical Tissue Network, Inc. dba TissueNet |
| City | Orlando |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-08-25 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Products were distributed to NJ, TX, NH, NY, PR; and to Turkey, Korea, and Chile. |
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