Events

Recall of AlloCraft DBM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LifeCell Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46780
  • Event Risk Class
    Class 3
  • Event Number
    Z-1299-2008
  • Event Initiated Date
    2007-10-17
  • Event Date Posted
    2008-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68246
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Acellular Matrix with Demineralized Bone - Product Code MQV
  • Reason
    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).
  • Action
    Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.

Device

AlloCraft DBM
  • Model / Serial
    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.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.
  • Product Description
    AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
  • Manufacturer
    LifeCell Corporation

Manufacturer

LifeCell Corporation
  • Manufacturer Address
    LifeCell Corporation, 1 Millennium Way, Somerville NJ 08876-3876
  • Manufacturer Parent Company (2017)
    Allergan Public Limited Company
  • Source
    USFDA