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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: Achilles with Bone Block Pre-sized. 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 #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0033 NLGIN10-0038 NLGIN10-0047 NLGIN10-0069
Recall Number B-2250-12
Classification Class III
Code Info Tissue ID #: AI1000040006, AI1000090005, AI1000090006, AI1000120005, AI1000160005, AI1000160006, AI1000380015, AI1000380016, AI10110030006, AI10110400005, AI10110400006
Product Distributed Qty 11 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.