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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 UltraTibialis (Anterior) is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description UltraTibialis (Anterior)***Size***Product Code FF84230***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***UltraTibialis (Anterior) ***FF84230 EXP:***TissueNet 800-465-8800***" Full Product Description: Ultra Tibialis Anterior
Recall Number B-1645-12
Classification Class II
Code Info Product ID: TN4211610077, TN4211610078
Product Distributed Qty 2 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.