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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 Initiated by Firm October 17, 2007
Date Posting Updated March 26, 2008
Recall Status1 Terminated 3 on May 14, 2008
Recall Number Z-1298-2008
Recall Event ID 46780
510(K)Number K052735  
Product Classification Acellular Matrix with Demineralized Bone - Product Code MQV
Product AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
Code Information Lot Numbers: B07F25I; Exp 4/2009; B07F25J: Exp 4/2009; and B07425H; Exp 3/2009..
Recalling Firm/
Manufacturer
LifeCell Corporation
1 Millennium Way
Somerville NJ 08876-3876
For Additional Information Contact Bonnie Samuel
908-947-1042
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 46 kits
Distribution All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = LIFECELL CORP.
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