LifeCell Corporation AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
Brand
LifeCell Corporation
Lot Codes / Batch Numbers
Lot Numbers: B07F25I, Exp 4/2009, B07F25J: Exp 4/2009, and B07425H, Exp 3/2009.
Products Sold
Lot Numbers: B07F25I; Exp 4/2009; B07F25J: Exp 4/2009; and B07425H; Exp 3/2009.
LifeCell Corporation is recalling AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Bran due to 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-ap. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NJ
Page updated: Jan 10, 2026