Z-1298-2008

AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg...

Name: Z-1298-2008 AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg...
Creator: LifeCell Corporation
Published: 2007-10-17
License: https://open.fda.gov/license/

LifeCell Corp / initiated 2007-10-17 / Terminated

FDA source

LifeCell Corporation began a recall of AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine on 2007-10-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1298-2008
Status: Terminated
Initiated: 2007-10-17
Posted: 2008-03-26
Terminated: 2008-05-14
Recalling firm: LifeCell Corp
Product: AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
Product code: MQV Filler, Bone Void, Calcium Compound
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 root cause: 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.
Product codes and lots: Lot Numbers: B07F25I; Exp 4/2009; B07F25J: Exp 4/2009; and B07425H; Exp 3/2009.

Product code MQV

K052735Class IIAllocraft DbmLifecell Corp. / cleared 2005-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)