Recall of Device Recall Poly Stim II Nerve Stimulator for Stryker Pain Pump

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Stimulator, nerve, battery-powered - Product Code BXN
  • Reason
    Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.
  • Action
    Stryker Instruments issued an "Urgent Medical Device Recall Notification" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to: 1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product. 3) Destroy all affected product using attached instructions. 4) Complete and return the Business Reply Form to the firm by fax. Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354


  • Model / Serial
    0507702223, 0524301373 and 0603705603.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT.
  • Product Description
    Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
  • Manufacturer


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