Events

Recall of Device Recall Howmedica HIp Stem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    36973
  • Event Risk Class
    Class 2
  • Event Number
    Z-0474-2007
  • Event Initiated Date
    2006-11-28
  • Event Date Posted
    2007-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49725
  • 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
    Hip Stem - Product Code KWL
  • Reason
    Lack of assurance of sterility (package integrity): anomalies in seal width and strength that may affect the integrity of the sterile barrier.
  • Action
    Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.

Device

Device Recall Howmedica HIp Stem
  • Model / Serial
    Hip Fracture Stem # 3; Catalog number 6942-0-030, Lot codes: 7238602, 7238603, 7238604, 7353002, 7353003, 7600501, 7600502, 7692501, 7692503, 7692504, 7692505, 7292506, 7935101, 7935102, 7935103, 7999701, 7999702, 7999703, 7999801, 7999803, 8152201, 8152203, 8152204, 8152205, 8152206, 8152207, 8152208, 8241801, 8241802, 8242101, 8252102, 8242103, 8345503, 8345504, 8531601, 8531901, 8532001, 8532301, 8532401, 8532501, 8532601, 8643301, 8643302, 8643303, 8643304, 8643305, 8850801, 8850802, 8850901, 8850902, 8850903, 9011101, 9044301, 9044302, 9044303, 9044304, 9090101, 9124401, 9400801, 9400802, 9400803, 9503202, 9574801, 9911802, 9911803, 9948101, 9948102, 10164601, 10164602, 10212501, 10317501, 10353702, 10353703, 10917801, 10917802, 10917803, 10917804, 10917806, 11064501, 11064503, 11092701, 11092702, 11092703, 11092704, 11092705, 11369401, 11369402, 11605501, 11607801, 12407001, 12407003, 12407005, 12407006, 12870602, 12870603, 12870604, 12947201, 12947202, 12947203, 13294601, 13294602, 13294603, 13294604, 13294605, 13294606, 13412101, 13412102, 13412103, 13412104, 13782202, 13782203, 13782204, 13782205, 14377903, 14412801, 14412804, 14412805, 14682701, 14682702, 14738901, 15236201, 15550301, 15550302, 15550303, 16059701, 16059703, 16059704, 16059705, 16059706, 16165503, 16499502, 16750801, 16937801, 16937802, 16937803, 16937804, 16937805, 16937806, 17540401 17540402, 17657902, 17657903, 17745101, 17842801, 17842802, 17842803, 18062101, 18062202, 18131401, 18131402, 18131403, 18448701, 18448702, 18594201, 18594202, 18594203, 18946901, 18946902, 19428801, 19673002, 19673003, 19673004, 19726201, 20304601, 20304602, 20304604, 20304607, 7023401R.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Howmedica Hip Fracture Stem System || No. 3 Femoral Component || Fenestrated || Sterile REF Catalogue #6942-0-030 || Made in Ireland
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA