• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

  • Print
  • Share
  • E-mail

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***" 4-10mm 15cc, 30cc, and 60cc Cancellous Chips: Product Code 0317AI, 4-10mm 15cc Cancellous Chips Product Code 0318Al, 4-10mm 30cc Cancellous Chips Product Code 0320Al. 4-10mm 60cc Cancellous Chips
Recall Number B-1628-12
Classification Class II
Code Info Tissue ID/Donor ID: Al1000082024, Al1000082025, Al1000082026, Al1000082027, Al1000082028, Al1000082029, Al1000112030, Al1000112005, Al1000112006, Al1000082031, Al1000082032, Al1000082033, Al1000082034, Al1000112007, Al1000112008, Al1000112009, Al1000112010, Al1000112011, Al1000112012, Al1000112013
Product Distributed Qty 20
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.