Events

Recall of RF Arthroscopy Probe

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

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
    49510
  • Event Risk Class
    Class 2
  • Event Number
    Z-0568-2009
  • Event Initiated Date
    2008-08-08
  • Event Date Posted
    2009-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73698
  • 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 and coagulation device - Product Code GEI
  • Reason
    Sterimed, inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. the removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. a breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable.
  • Action
    Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

Device

RF Arthroscopy Probe
  • Model / Serial
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Product Description
    RF Arthroscopy Probe || Model #'s: || ARTA1325-01 || ARTA1335-01 || ARTA1345-01 || ARTA1730-01 || ARTA2630-01 || ARTA3625-01 || ARTA4330-01 || ARTAS1335-01 || ARTAS4630-01 || ARTASC1335-01 || ARTASC2530-01 || ARTASC4250-01 || ARTASC4830-01 || ARTASC5000-01 || ARTASC5500-01 || ARTEIC4845-01 || MIT225203 || MIT225301 || MIT225302 || MIT225305 || MIT225350 || MIT225360 || SMI7209681 || SMI7209682 || SMI7209683 and || STR278-510-500 || These devices are designed for general surgical use, including orthopedic and arthroscopic applications or resection, ablation, excision of soft tissue, hemostatis of blood vessels, and coagulation of soft tissue.
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc
  • Manufacturer Address
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA