Events

Recall of Device Recall Gamma

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
    25585
  • Event Risk Class
    Class 2
  • Event Number
    Z-0580-03
  • Event Initiated Date
    2003-01-20
  • Event Date Posted
    2003-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26100
  • 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
    Bit, Drill - Product Code HTW
  • Reason
    Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
  • Action
    Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.

Device

Device Recall Gamma
  • Model / Serial
    1212-5300S -- Gamma AO Drill 5.5x300mm-- K626400; K626401; K626402; K821823; K821824.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
  • Product Description
    Gamma AO Drill 5.5x300mm
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

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