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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

Product Description Bone
Recall Number B-2183-13
Classification Class II
Code Info 0111510146; 0111510147; 0111510148; 0111510131; 0111510132; 0111510133; 0111510134; 0111510135; 0111510136; 0111510137; 0111510138; 0111510139; 0111510140; 0111510066; 0111510068; 0111510070; 0111510071; 0111510072; 0111510073; 0111510074; 0111510075; 0111510076; 0111510077; 0111510078; 0111510079; 0111510080; 0111510081; 0111510082; 0111510083; 0111510091; 0111510096; 0111510097; 0111510098; 0111510099; 0111510100; 0111510101; 0111510102; 0111510103; 0111510104; 0111510105; 0111510106; 0111510107; 0111510108; 0111510109; 0111510110; 0111510111; 0111510112; 0111510113; 0111510114; 0111510115; 0111510121; 0111510123; 0111510150; 0111510152; 0111510153; 0111510154; 0111510119; 0111510149; 0112840072; 0112840073; 0112840074; 0112840075; 0112840076; 0112840077; 0112840078; 0112840080; 0112840081; 0112840086; 0112840082; 0112840085;
Product Distributed Qty 70 bone allografts
Reason For Recall Human tissue allografts, associated with positive culture results, were distributed.

Event Detail

Event Id 65599
Product Type Biologics
Status Terminated
Recalling Firm University Of Miami Miller School of Medicine Tissue Bank
City Miami
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-23
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Mississippi; Puerto Rico; Maryland; Florida; Guatemala; New York
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