Events

Recall of 12 Instrument Sterilization Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

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
    68045
  • Event Risk Class
    Class 2
  • Event Number
    Z-1544-2014
  • Event Initiated Date
    2014-04-16
  • Event Date Posted
    2014-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126854
  • 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
    Electrosurgical, cutting & coagulation & - Product Code GEI
  • Reason
    Gravity sterilization parameters provided in the 12 instrument sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
  • Action
    Stryker sent an Urgent Device Corrections letters dated April 18, 2014 to all US customers via certified mail. Stryker Sales representative and Stryker international distributors were notified with the letter and response card by e-mail. International sites are responsible for notifying customers. The letter identified the affected product, problem, potential hazards and actions to be taken. Customers were instructed to complete and sign the enclosed Acknowledgement of Receipt form and scan and e-mail to endorecall@stryker.com. For questions call 1-800-624-4422 option 3 or via email at endorecall@stryker.com.

Device

12 Instrument Sterilization Tray
  • Model / Serial
    Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1,  48639-1-8, 021464-3, 40288-1-1, 43020, 43893-1-6, 27701, 43104-1-1,  36175-1-1, 48956-1-1, 23027, 40629-3-,1, 43622, 43893-1-7, 29129,  43270-1-1, 36421-1-1, 48956-1-1A, 23398, 40721-1-1, 50476,  43893-1-8, 29670, 43523-1-1, 36424-1-1, 51304-1-1, 23542,  41231-4-1, 54990, 43893-1-9, 30250, 43523-1-1A, 37251-1-1,  51304-1-1A, 23846, 41478-1-1, 7J1, 48639-1-2, 30919, 43674-1-1,  37392-1-1, 52123-1-1, 24073, 41745-1-1, 123, 48639-1-3, 3218., 43893-1-1, 37794-1-1, 52956-1-1, 24511, 42086-1-1, 28646-1-1,  48639-1-4, 33226, 43893-1-10, 38867-1-1, 54346-1-1, 26445,  42306-1-1, 29005-1-1, 48639-1-5, 33961, 43893-1-1, 1SS15327, 26843,  42526-1-1, 30384-1-1, 48639-1-7, 35933, 43893-1-12, 37991, 36610,  43893-1-13, 39219, 43893-1-2, 43893-1-14.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    12-Instrument Sterilization Tray; || Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA