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U.S. Department of Health and Human Services

Class 3 Device Recall AlloCraft DBM

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 Class 3 Device Recall AlloCraft DBM see related information
Date Posted March 26, 2008
Recall Status1 Terminated on May 14, 2008
Recall Number Z-1299-2008
Recall Event ID 46780
510(K)Number K052735 
Product Classification Acellular Matrix with Demineralized Bone - Product Code MQV
Product AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
Code Information Lot Numbers: B06E02E; Exp 3/2008; B06E02F, Exp. 3/2008; B07C29B, Exp 2/2009; B07E14E, Exp 3/2009; B07G24B, Exp 5/2009; B07G24C, Exp 5/2009; B07G24E, Exp. 5/2009; and B07G24F, Exp 5/2009.
Recalling Firm/
LifeCell Corporation
1 Millennium Way
Somerville NJ 08876-3876
For Additional Information Contact Bonnie Samuel
Manufacturer Reason
for Recall
Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)
FDA Determined
Cause 2
Release of Material/Component prior to receiving test results
Action Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.
Quantity in Commerce 110 kits
Distribution All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = LIFECELL CORP.