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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description Products: 1-2mm 1cc Cortical Cancellous Chips, 1-2mm 2cc Cortical Cancellous Chips,1-2mm 5cc Cortical Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0020 NLGIN10-0031 NLGIN10-0035 NLGIN10-0038 NLGIN10-0047
Recall Number B-2232-12
Classification Class III
Code Info Tissue ID #: AI1000200536, AI1000200537, AI1000200538, AI1000200539, AI1000200540, AI1000310510, AI1000350505, AI1000350506, AI1000350507, AI1000350508, AI1000350509, AI1000350510, AI1000350511, AI1000350512, AI1000350513, AI1000350514, AI1000350515, AI1000350516, AI1000350517, AI1000350518, AI1000350519, AI1000350520, AI1000350521, AI1000350522, AI1000350523, AI1000350524, AI1000350525, AI1000350526, AI1000380518, AI1000380519, AI1000380520, AI1000380521, AI1000380522, AI1000380523, AI1000380525, AI1000380526, AI1000380527, AI1000380528, AI1000380529, AI1000380530, AI1000380531, AI1000380532, AI1000380533, AI1000380534, AI1000380535, AI1000380536, AI1000380537, AI1000380538, AI1000380539, AI1000380543, AI1000380544, AI1000380545, AI1000380546, AI1000380547, AI1000380549, AI1000380550, AI1000380552, AI1000380554, AI1000470508, AI1000470509, AI1000470510, AI1000470511, AI1000470512, AI1000470513, AI1000470514, AI1000470515, AI1000470516, AI1000470517
Product Distributed Qty 68 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 60098
Product Type Biologics
Status Ongoing
Recalling Firm Allograft Innovations, LLC
City Gainesville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Products were distributed domestically to hospitals nationwide and internationally to Israel, South Korea, United Kingdom, and Turkey.
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