Events

Recall of Device Recall Service parts for Crank Screw Assembly

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical 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
    54265
  • Event Risk Class
    Class 2
  • Event Number
    Z-2343-2010
  • Event Initiated Date
    2010-02-26
  • Event Date Posted
    2010-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93868
  • 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
    Bed, manual - Product Code FNJ
  • Reason
    The fowler of the bed is raised by a crank. the crank consists of a steel screw that moves through a brass nut. over time the screw can wear the threads on the brass nut. the screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. in addition the fowler can become inoperable over time with excessive wear of the brass nut. t.
  • Action
    The firm, Stryker Medical, sent an "Urgent Medical Device Correction" letter dated February 26, 2010, to all customers. The letter describes the product, problem and action to be taken by customers. The letter states that Stryker field service tech will contact the firm and perform device corrections within four months. The customers were instructed to locate the recalled stretchers and verify that there is no grinding noise when activating the fowler. If the fowler exhibited a grinding noise, the customers were instructed to remove the stretcher from service and contact the recalling firm at 800-STRYKER, option 3. Note: Do not put the stretcher back into service until it is repaired by our field service representative. The customers were also instructed to return the enclosed post card to confirm receipt of this notice; inform any new users and advise the firm of new locations if any of the listed stretchers were on loan or sold, and advise the firm of the obsolescence by providing the serial numbers if any of the listed stretchers were disposed of. If you have any urgent questions or concerns, contact (269) 324-6884. Normal hours are Monday-Friday 8am-5pm(EST).

Device

Device Recall Service parts for Crank Screw Assembly
  • Model / Serial
    There is no code.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including Australia, Canada, Chile, China, France, Germany, Greece, Spain, Italy, Japan, South Africa, Taiwan, Korea, Singapore, and UK.
  • Product Description
    Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker Medical 3800 E. Centre Ave Portage MI 49002. || Intended use: Service parts are replacement parts for the eye surgery stretcher.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA