Events

Recall of Device Recall Howmedica Osteonics

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

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
    26863
  • Event Risk Class
    Class 2
  • Event Number
    Z-1143-03
  • Event Initiated Date
    2003-07-17
  • Event Date Posted
    2003-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28600
  • 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
    Instrument, Cutting, Orthopedic - Product Code HTZ
  • Reason
    Scorpio femoral resection guides have the potential to remove more bone than necessary.
  • Action
    Product recall letters and product accountability forms were sent via FedEx to all Branches/sales agents on July 17, 2003. For the Canadian and International customers, the recall notification was also sent on July 17, 2003. All devices are to be returned to Howmedica Osteonics, Mahwah, NJ.

Device

Device Recall Howmedica Osteonics
  • Model / Serial
    Catalog No: 8050-5103; 8050-5105; 8050-5107; 8050-5109; 8050-5111; 8050-5113.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The catalog numbers were sent to Howmedica Osteonics Sales Representatives/agents, one Canada Howmedica Sales Representative, and one International Howmedica location in Ireland.
  • Product Description
    Femoral Resection Guide, Scorpio L.R.S. Instrumentation.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Manufacturer Address
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA