Events

Recall of Device Recall External Compression Device

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
    56800
  • Event Risk Class
    Class 2
  • Event Number
    Z-0330-2011
  • Event Initiated Date
    2010-08-30
  • Event Date Posted
    2010-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94535
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Variations in the outer diameter of the shaft of the external compression device and the inner diameter of the nail holding screw may make assembly of these 2 instruments not possible.
  • Action
    Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to: Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation. Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to (201) 831-6069 within 5 days of receipt of notice. A Stryker representative would contact the customer with details for return of the product. For any questions regarding this recall call (201) 972-2100.

Device

Device Recall External Compression Device
  • Model / Serial
    Catalog Number: 1806-1601; Lot code: K228113
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX
  • Product Description
    External Compression Device; 1 unit per package || Stryker Trauma GmbH; || Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || Active Apposition/compression is achieved by threading the External Compression Device into the Nail holding Screw. While being threaded into the Nail Holding Screw the tip of the External Compression Device will contact the (shaft screw(cross screw) and will push the screw in distal direction. As the cross screw is screwed into the bone of the patient, the bone fragment will be moved too is distal direction. Finally both sides of the bone fracture will be pressed together - compression is now applied to the fracture side.
  • 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