Events

Recall of Device Recall Hummer IV Microdebrider System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. 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
    67775
  • Event Risk Class
    Class 2
  • Event Number
    Z-1247-2014
  • Event Initiated Date
    2014-03-18
  • Event Date Posted
    2014-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126273
  • 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
    Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
  • Reason
    Stryker instruments is voluntarily recalling the single use 2.5mm aggressive blade because the line on the affected part (p/n 5290-928-000, lot #13280cg2) was a straight line without a number scale or logo. the line required for this part number includes a number scale that goes from 1cm  7cm.
  • Action
    Stryker Instruments sent an Recall Notification dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF)to all affected locations. Please indicate each location on the BRF. A FedEx shipping label will be emailed to each account upon receipt of the signed Business Reply Form. This label will allow the account to return the product to be destroyed. A Business Reply Form will be included in each mailing. Return of this form will serve as confirmation that the account has received the notification and executed the recall. Follow up phone calls, emails, and faxes will be sent to non-responding accounts as necessary. Product destruction will be handled at Stryker Instruments, Kalamazoo. Labeling will be defaced and the Aggressive Blades will be disposed of in the trash compactor. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-2921

Device

Device Recall Hummer IV Microdebrider System
  • Model / Serial
    P/N 5290-628-000, Lot #13280CG2
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia
  • Product Description
    2.5MM Aggressive Blade || Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. || ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only || It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA