Events

Recall of Device Recall Howmedica Osteonics Corp.

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
    67734
  • Event Risk Class
    Class 2
  • Event Number
    Z-1317-2014
  • Event Initiated Date
    2014-02-03
  • Event Date Posted
    2014-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126186
  • 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
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Reason
    Stryker received a report from the field indicating that a citation tmzf ha 132 degrees neck angle v40 hip stem - left size # 4 was identified in a packaging associated with a citation tmzf ha 132 degrees neck angle v40 hip stem - right size #3.
  • Action
    Stryker sent an Urgent Medical Device Recall Notification letters and Product Accountability Forms to Hospital Risk Management, Chief of Orthopaedics, and Surgeons via Fed Ex with return receipt on February 26, 2014. The letter identified the affected product, problem and actions to be taken. Customer were instructed to return the affected product to the attention of Regulatory Compliance. Please attach the fluorescent orange PRODUCT REMEDIATION sticker to your return. For questions call 201-972-2100.

Device

Device Recall Howmedica Osteonics Corp.
  • Model / Serial
    v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101, v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801, lot code 43316901, v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
  • 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