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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: Tibialis Tendon - Posterior. 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 #: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0066 NLGIN10-0069
Recall Number B-2259-12
Classification Class III
Code Info Tissue ID #: AI090024C0009, AI090024C0010, AI1000040011, AI1000040012, AI1000050009, AI1000050010, AI1000090011, AI1000090012, AI1000120011, AI1000120012, AI1000130010, AI1000160013, AI1000160014, AI1000210012, AI1000210013, AI1000240011, AI1000250011, AI1000250012, AI1000380007, AI1000380008, AI1000660006, AI10110030012, AI10110030013, AI10110400010, AI10110400011
Product Distributed Qty 25 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.