Events

Recall of SuperCable ScrewDriver, 3.5mm Hex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kinamed 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
    58808
  • Event Risk Class
    Class 2
  • Event Number
    Z-2588-2011
  • Event Initiated Date
    2010-08-18
  • Event Date Posted
    2011-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100337
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Reason
    The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening.
  • Action
    The firm, Kinamed Inc., sent a recall letter dated August 18, 2010 to consignees/customers via FedEx. The letter described the product, problem and actions to be taken. The customers were instructed to Immediately examine their stock and return any Kinamed SuperCable Screwdriver, 3.5mm Hex bearing these lot numbers, along with the completed attached Effectiveness Check Form and shipment under RMA #74567 to the attention of: "Director of Quality Assurance" Kinamed, Inc. 820 Flynn Road Carnarillo, CA 93012-8701 Note: The Kinamed sales agent shipped and had the product replaced for the customers. If you have any questions, please contact (303)-681-2208, (805) 384-2748 or (800) 827-5775

Device

SuperCable ScrewDriver, 3.5mm Hex
  • Model / Serial
    Lot Numbers K12899 (2pcs) & K12985 (3pcs)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) state of: CO and country of: Columbia.
  • Product Description
    Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 || The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. || Subsequent || Product Codes: HWC, JDQ.
  • Manufacturer
    Kinamed Inc

Manufacturer

Kinamed Inc
  • Manufacturer Address
    Kinamed Inc, 820 Flynn Rd, Camarillo CA 93012
  • Manufacturer Parent Company (2017)
    Kinamed Inc.
  • Source
    USFDA