Date Initiated by Firm | October 17, 2007 |
Date Posted | March 26, 2008 |
Recall Status1 |
Terminated 3 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
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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/ 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 | 110 kits |
Distribution | All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MQV
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