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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description Cancellous Crushed is labeled in part: "***Tissue ID:***Description: Cancellous Crushed***Size 30cc-4mm-10mm***Product Code FD55330R***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Cancellous Crushed***FD55330R EXP:***TissueNet 800-465-8800***"
Recall Number B-1639-12
Classification Class II
Code Info Product ID: TN4211610051, TN4211610052, TN4211610053, TN4211610054, TN4211610055, TN4211610056, TN4211610057, TN4211610058, TN4211610059, TN4211610060, TN4211610061, TN4211610062, TN4211610063, TN4211610064, TN4211610065
Product Distributed Qty 15 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.