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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 2cc Cancellous Chips; .5-1mm 15cc Cancellous Chips; .5-1mm 30cc Cancellous Chips. Cancellous Chips. Product s are 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: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0018 NLGIN10-0020 NLGIN10-0024 NLGIN10-0033
Recall Number B-2227-12
Classification Class III
Code Info Tissue ID #: AI090024C2013, AI090024C2014, AI090024C2015, AI090024C2016, AI090024C2017, AI090024C2018, AI1000042016, AI1000052013, AI1000052014, AI1000052015, AI1000052016, AI1000052017, AI1000092019, AI1000092020, AI1000122013, AI1000122014, AI1000122015, AI1000122016, AI1000122017, AI1000122018, AI1000122019, AI1000122020, AI1000122021, AI1000122022, AI1000162019, AI1000182005, AI1000202018, AI1000202019, AI1000202020, AI1000202021, AI1000242009, AI1000242010, AI1000242011, AI10110402005, AI10110402006, AI10110402007, AI10110402008
Product Distributed Qty 37 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.