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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

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

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 Letter
Distribution Pattern Arizona; Pennsylvania; South Carolina; Oregon; Maryland; California; Florida