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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Tendon products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label.
Recall Number B-2146-12
Classification Class III
Code Info Graft ID#s B100123001; B100123002; B100123007; B100123008; B100123009; B100123010; B100124001; B100124002; B100124003; B100124005; B100124006; B100124007; B100124008; B100124011; B100124012; B100124013; B100125003; B100125004; B100126001; B100126002; B100126006; B100126014; B100127002; B100127003; B100127004; B100141001; B100141006; B100141007; B100141008; B100141009; B100141012; B100141013; B100141014; B100141015; B100141016; B100141017; B100142001; B100142002; B100142003; B100142005; B100142006; B100142011; B100142012; B100142013; B100145007; B100145008; B100152001; B100152002; B100152007; B100153001; B100153005; B100153006; B100155001; B100155004; B100155005; B100159002; B100159003; B100159004; B100159007; B100187001; B100187002; B100187007; B100187008; B100187009; B100187010; B100187012; B100187013; B100187014; B100188006; B100188009; B110002001; B110002002; B110002003; B110002004; B110002007; B110002008; B110002009; B110002010; B110002011; B110002012; B110034001; B110034002; B110043001; B110043009; B110048001; B110048002; B110048005; B110048006; B110048009; B110048010; B110048011; B110048012; B110049005; B110049006; B110049007; B110049011; B110065001; B110065004; and B110091004
Product Distributed Qty 100 units
Reason For Recall Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 60075
Product Type Biologics
Status Ongoing
Recalling Firm Bacterin International Inc. Biologics Division
City Belgrade
State MT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed nationwide