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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description 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 CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" .5-1mm 15cc, 30cc, and 1cc Cancellous Chips: Product Code 0308Al, .5-1mm 15cc Cancellous Chips Product Code 0309AI, .5-1mm 30cc Cancellous Chips Product Code 0326AI, .5-1mm 1cc Cancellous Chips
Recall Number B-1626-12
Classification Class II
Code Info Tissue ID/Donor ID# Al1000082007, Al1000082008, Al1000082009, Al1000082010, Al1000082011, Al1000112020, Al1000112021, Al1000112022, Al1000112023, Al1000112024, Al1000112025, Al1000112026, Al1000112027, Al1000112028, Al1000112029
Product Distributed Qty 15
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 60112
Product Type Biologics
Status Ongoing
Recalling Firm Allograft Innovations, LLC
City Gainesville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI.