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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Tendon
Recall Number B-2413-13
Classification Class III
Code Info Donor ID 101084060; Serial Numbers: 8464116, 8464117, 8464118, 8464120, 8464121, 8464122
Product Distributed Qty 6 allografts
Reason For Recall 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.

Event Detail

Event Id 65637
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; Oklahoma; Korea, Republic Of(South); Alabama; Louisiana; Florida; Indiana; Texas