Events

Recall of Device Recall Depth Gauge

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
    54198
  • Event Risk Class
    Class 2
  • Event Number
    Z-0796-2010
  • Event Initiated Date
    2009-12-22
  • Event Date Posted
    2010-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87811
  • 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
    Depth Gauge - Product Code HTJ
  • Reason
    The depth measuring gauges have 5 scale marking instead of the required 4 scale markings.
  • Action
    Urgent Product Recall letters, dated December 22, 2009, were sent to all Stryker Branches/Agencies. Letters were also sent to hospitals and surgeons that use the VariaAx Elbow System were also notified. All letters were sent by Federal Express. The letters identified the affected product, stated the issue, and the hazards involved. It also asked customers to examine their inventory and hospital locations to identify affected products. All affected products are to be retrieved and returned to their branch or agency warehouse for reconciliation. All products should be reconciled on the attached Product Accountability Form and a copy should be faxed to 201-831-6069 within 5 days of receipt of the notice. Follow the instructions for shipping the affected product back to the firm. Questions should be directed to 201-972-2100.

Device

Device Recall Depth Gauge
  • Model / Serial
    Lot code: U09984  VariaAx Elbow System Instrument Set - kitted, material transaction lots # U23151, U24021, U25906 and U29985 all contain one piece of the affected recalled catalog number.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Depth Gauge; Catalog Number: 703707; || Stryker Trauma AG, CH 2545 Selzach; || Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || This product is sold separately or as part of Kit # 990256. || The depth gauge is an instrument in the VariAx Elbow System. Depth gauges are tools used intra-operatively, to aid in correct screw selection. They can be used with a plate, or directly on bone.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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