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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: 6mm Lordotic Cervical Spacer. 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 #: NLGIN10-0012 NLGIN10-0024 NLGIN10-0069
Recall Number B-2247-12
Classification Class III
Code Info Tissue ID #: AI1000124005, AI1000124006, AI1000124007, AI1000124008, AI1000244022, AI1000244023, AI1000244024, AI1000244025, AI1000244026, AI1000244027, AI10110034011, AI10110034012, AI10110034013, AI10110034014, AI10110034015, AI10110034016, AI10110034017, AI10110034018, AI10110034019, AI10110034020, AI10110034021, AI10110034022, AI10110034023, AI10110034024, AI10110034025, AI10110034026, AI10110034028
Product Distributed Qty 27 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.