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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 UltraC1 or C2, Cervical is labeled in part: "***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:***UltraC1, Cervical***FD57506, 6mm Small label: "***ID:***UltraC1, Cervical***FD57507, 7mm Small label: "***ID:***UltraC1, Cervical***FD57508, 8mm Small label: "***ID:***UltraC2, Cervical***FD57607, 7mm
Recall Number B-1637-12
Classification Class II
Code Info Product ID: FD57506, 6mm TN4211610002, TN4211610003, TN4211610004, TN4211610005, TN4211610006 TN4211610007, TN4211610008 Product ID: FD57507, 7mm TN4211610009, TN4211610010, TN421161001, TN4211610012, TN4211610013 TN4211610014 Product ID: FD57508, 8mm TN4211610015 Product ID: FD57607, 7mm TN4211610029, TN4211610030, TN4211610031, TN4211610032, TN4211610033
Product Distributed Qty 19 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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