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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: .5-1mm 1cc Cortical Cancellous Chips, .5-1mm 2cc 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 #: NLGIN10-0013 NLGIN10-0024 NLGIN10-0025 NLGIN10-0035 NLGIN10-0038 NLGIN10-0066
Recall Number B-2231-12
Classification Class III
Code Info Tissue ID#: AI1000130505, AI1000130506, AI1000130507, AI1000130508, AI1000130516, AI1000130517, AI1000130518, AI1000130519, AI1000240509, AI1000240510, AI1000240511, AI1000240512, AI1000240513, AI1000240514, AI1000240515, AI1000240516, AI1000240517, AI1000240518, AI1000240519, AI1000240521, AI1000240522, AI1000240523, AI1000240524, AI1000240525, AI1000240526, AI1000240528, AI1000240529, AI1000240530, AI1000240531, AI1000240532, AI1000240533, AI1000240534, AI1000240535, AI1000240536, AI1000240537, AI1000240539, AI1000240540, AI1000240544, AI1000240545, AI1000250524, AI1000250525, AI1000250526, AI1000250527, AI1000250528, AI1000250529, AI1000350535, AI1000350536, AI1000350537, AI1000350538, AI1000350539, AI1000350552, AI1000350553, AI1000350554, AI1000350555, AI1000350556, AI1000350557, AI1000350558, AI1000350559, AI1000350560, AI1000350561, AI1000380506, AI1000380507, AI1000380508, AI1000380509, AI1000380510, AI1000380511, AI1000380512, AI1000380513, AI1000380515, AI1000380516, AI1000660505, AI1000660506, AI1000660507, AI1000660508, AI1000660509, AI1000660510, AI1000660511, AI1000660512, AI1000660513, AI1000660514, AI1000660515, AI1000660516, AI1000660517, AI1000660518, AI1000660519, AI1000660520, AI1000660521, AI1000660522, AI1000660523, AI1000660524, AI1000660525, AI1000660526, AI1000660527, AI1000660528, AI1000660529, AI1000660530, AI1000660531, AI1000660532, AI1000660533, AI1000660534, AI1000660535
Product Distributed Qty 101 Tissues
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.