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U.S. Department of Health and Human Services

Class 3 Device Recall AlloCraft DBM

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 Class 3 Recall
AlloCraft DBM
see related information
Date Posted March 26, 2008
Recall Status1 Terminated on May 14, 2008
Recall Number Z-1298-2008
Recall Event ID 46780
Premarket Notification
510(K) Number
K052735 
Product Classification Filler, Bone Void, Calcium Compound - 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, New Jersey 08876-3876
Consumer Instructions Return product to place of purchase for a full refund
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to 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 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.
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