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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 65634
Product Type Biologics
Status Terminated
Recalling Firm RTI Biologics, Inc.
City Alachua
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-17
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Tennessee; Ohio; Colorado; Indiana; New York; Texas

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Bone Donor ID 101082885; Serial Numbers: 7838730, 7838732, 7838733, 7838734, 7838735, 7838736, 7838737, 7838738, 7838739, 7838740, 7838741, 7838742, 7838743, 7838744, 7838745, 7838746, 7838747, 7915488, 7915489, 7915490, 7915491, 7915492, 7915493, 7915494, 7915495, 7915496, 7915497, 7931192, 7931193 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 29 allografts B-2412-13
Tendon Donor ID: 101082885; Serial Numbers: 8519769, 8519770, 8519771, 8519772, 8519773, 8519776, 8519777 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 7 allografts B-2411-13
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