Events

Recall of Stryker

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
    60145
  • Event Risk Class
    Class 2
  • Event Number
    Z-0195-2012
  • Event Initiated Date
    2011-10-18
  • Event Date Posted
    2011-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104527
  • 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
    Driver, wire, and bone drill, manual - Product Code DZJ
  • Reason
    There is a potential for these blades to break where the blade is welded on to the arbor. this hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli.
  • Action
    The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated October 18, 2011 to Risk Managers, Office Managers, and Oral Surgeons. The letter described the products under recall, the problem and a series of actions to be taken. Customers were asked to immediately locate recalled products and quarantine. Products were to be shipped back to Stryker. The letter included a Business Reply Form to be faxed back to Stryker Instruments Regulatory Department, 866-521-2762. The letter instructs to forward this notification to all affected locations if the recalled products were further distributed. Customers with questions can call Stryker at 1-800-253-3210.

Device

Stryker
  • Model / Serial
    06213017, 08269017, 06230017, 08297027, 06247017, 08322017, 06257017, 08325017, 06279017, 09020017, 06306017, 09050017, 06355027, 09083017, 07025017, 09135017, 07043017, 09209017, 07067017, 09233017, 07080017, 09246017, 07114017, 09330017, 07157017, 10046017, 07172017, 10074017, 07183017, 10083017, 07197017, 10091017, 07211017, 10180017, 07220017, 10194017, 07246017, 10217017, 07282017, 10231017, 07323017, 10266017, 07356017, 10272017, 08003017, 10327027, 08017017, 10335017, 08049017, 11004017, 08064017, 11012017, 08078017, 11080017, 08141017, 11119017, 08206017, 11153017, 08248017, 11165017.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Brazil, Canada, China, Germany, Greece, Hong Kong, India, Jordan, Miramar, Saudi Arabia, Singapore, Spain, Switzerland, United Kingdom.
  • Product Description
    IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker Instruments, Kalamazoo, MI. || Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.
  • 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