Events

Recall of InterPulse Handpiece Set With Bone Cleaning Tip and Suction Tube

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
    57470
  • Event Risk Class
    Class 2
  • Event Number
    Z-0951-2011
  • Event Initiated Date
    2010-10-04
  • Event Date Posted
    2011-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96298
  • 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
    Lavage, jet - Product Code FQH
  • Reason
    There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
  • Action
    Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge. For questions regarding this recall call (269) 323-7700.

Device

InterPulse Handpiece Set With Bone Cleaning Tip and Suction Tube
  • Model / Serial
    Part Number 0210-114-000;  Lot Number 09363012; Expires 12/1/2011
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (including all 50 states) and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK.
  • Product Description
    The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. || The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
  • 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