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 |
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