Events

Recall of Device Recall 3.5mm Super 90S SERFAS Energy Suction Probe

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
    50825
  • Event Risk Class
    Class 2
  • Event Number
    Z-0972-2009
  • Event Initiated Date
    2008-06-20
  • Event Date Posted
    2009-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77412
  • 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 & Accessories - Product Code GEI
  • Reason
    The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.
  • Action
    On 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed "acknowledgment of receipt" card and return it to Stryker Endoscopy or fax it to 408-754-2521 with the customer's account info included. If there are any questions regarding the notice, a Regulatory Affairs Representative should be contacted at 408-754-2161 or 408-754-2000.

Device

Device Recall 3.5mm Super 90S SERFAS Energy Suction Probe
  • Model / Serial
    08065AE2, 08066AE2, 08070AE2, 08079AE2, 08084AE2, 08086AE2, 08080AE2, 08085AE2, 08087AE2, 08088AE2, 08129AE2, 08128AE2, 08130AE2, 08136AE2, 08137AE2, 08140AE2, 08149AE2, 08154AE2, and 08157AE2
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; || Model Number: 279-351-300; || Manufactured By: || Stryker Endoscopy, Puerto Rico
  • 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