Events

Recall of Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach H

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
    57292
  • Event Risk Class
    Class 2
  • Event Number
    Z-0815-2011
  • Event Initiated Date
    2010-11-01
  • Event Date Posted
    2010-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95764
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The cuttingedge advantage rasp handle, straight rasp handle, and specialty head center accolade broach handle may fracture in two pieces along the width of the body under the striking plate. this may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site.
  • Action
    Stryker issued a Product Correction Bulletin dated November 2010 to their consignees, alerting surgeons of the need to inspect the instruments before and after each surgical use, and, if a defect is detected, to contact Stryker for return of the product. Stryker can be contacted at 201 831-5288 concerning this issue. In response to their revised strategy, Stryker issued notification letters and product recall acknowledgement forms to their branches and agencies on 2/17/2011 for 2/18/2011 delivery via Fed Ex and to their hospital risk managers on 2/18/2011 for 2/21/2011 delivery via Fed ex.

Device

Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center...
  • Model / Serial
    CuttingEdge Advantage Rasp Handle - Catalog number 1100-1000; All lot codes  Straight Rasp Handle - Catalog number 1440-1400; All lot codes  Specialty Head Center Accolade Broach Handle - Catalog number I-H088HF00, I-H1389HF00 ; All lot codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throughout the US, the countries of Canada and Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin America.
  • Product Description
    CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;
  • 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