Events

Recall of Device Recall Stryker 4MM XX COARSE ROUND DIAMOND BUR, Super Long

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Division of Stryker Corporation.

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
    57505
  • Event Risk Class
    Class 2
  • Event Number
    Z-1243-2011
  • Event Initiated Date
    2010-11-30
  • Event Date Posted
    2011-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96415
  • 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
    drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Reason
    Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
  • Action
    The firm, Stryker, sent a "MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 2, 2010 to all customers. The letter described the product, problem and the action to be taken by the customers. The customer were asked to complete and fax in the business reply form indicating they have received the notification and to indicate whether or not they have affected product on hand, and send back any affected product to Regulatory Affairs at Stryker Instruments. Stryker will then send a replacement product to the customer. Upon receipt of the completed business reply form, the customer will be contacted to arrange return of any affected product they have in their inventory. Once the affected product is received, a replacement 5190 TPS Series Bur will be sent to the customer. For questions regarding this recall, please contact Stryker Instruments at 1-800-800-4236 ext. 3584 or kathleen.kelly.smith@stryker.com.

Device

Device Recall Stryker 4MM XX COARSE ROUND DIAMOND BUR, Super Long
  • Model / Serial
    Part Number 5190013140, Lot 9188017
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.
  • Product Description
    Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. || These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA