Events

Recall of SERFAS

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
    60301
  • Event Risk Class
    Class 2
  • Event Number
    Z-0265-2012
  • Event Initiated Date
    2011-10-24
  • Event Date Posted
    2011-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104990
  • 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 device - Product Code GEI
  • Reason
    An increased number of complaints for tip breaks were observed for the 3.5mm super 90-s serfas energy suction probes manufactured from june to august 2011.
  • Action
    Stryker Endoscopy Urgent Medical Device Removal notifications datyed October 25, 2011, were sent to all consignees via traceable mail. Sales representatives and regional managers were notified by e-mail. Product is to be returned to Stryker Endoscopy using the pre-paid shipping label. Replacement product may be obtained by calling Stryker at 1-800-624-4422. The enclosed Acknowledgement receipt form is to be completed and returned. Questions or comments may be directed to Stryker at 1-800-624-4422 or e-mail at 90S@stryker.com.

Device

SERFAS
  • Model / Serial
    Model number: 279-351-300; Lots 11161AE2 to 11241AE2, Lots are numbered sequentially using the middle three numbers, i.e 161-241.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including USA, Australia, Canada, China, Greece, Hong Kong, India, Italy, Japan, France, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland and the United Kingdom
  • Product Description
    Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;
  • 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