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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 63026
Product Type Biologics
Status Terminated
Recalling Firm RTI Biologics, Inc.
City Alachua
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-31
Initial Firm Notification of
Consignee or Public
Distribution Pattern Arizona; Pennsylvania; South Carolina; Oregon; Maryland; California; Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Tendon 7576144; 7576145; 7576146; 7576147; 7576148; 7576149; 7576150 Class II Human tendons, with a culture positive for coagulase negative Staphylococcus, were distributed. 7 B-2524-12