Events

Recall of Device Recall Arthrex Reciprocating Saw Attachment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by W & H DentalWerk Buermoos GMBH.

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
    59146
  • Event Risk Class
    Class 2
  • Event Number
    Z-2879-2011
  • Event Initiated Date
    2011-05-24
  • Event Date Posted
    2011-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101341
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    Reciprocating saw attachment v 600 sr (ref: 17306210), screws can become loose or come off (the attachment) and fall into the surgical wound and may not be noticed due to its small size.
  • Action
    Madrimed GmbH (Distributor partner) of W&H; Dentalmechanik GmbH sent a letter dated May 24, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were ask to advise their users to check the adapters thoroughly before and after each application, until the conversion of all attachments have been completed and to send all products that need to be converted to the nearest service centers. W&H; decided to convert all products that might be affected in their service centres and equip them with an additional security device. If you have any questions, call +43627462360 or email: regulatory@wh.com.

Device

Device Recall Arthrex Reciprocating Saw Attachment
  • Model / Serial
    Serial Numbers: 1106 through1310
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Austia, Australia, Canada, Czech Republic, Denmark, France, Germany, Italy, Kuwait, Malaysia, Netherlands, Russia, Slovakia, South Africa, Spain, Taiwan, Turkey and United Kingdom.
  • Product Description
    Arthrex Reciprocating Saw Attachment || Type: V-600SR || Distributed by: Arthrex Inc., Naples, Florida United States || The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E; Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries
  • Manufacturer
    W & H DentalWerk Buermoos GMBH

Manufacturer

W & H DentalWerk Buermoos GMBH
  • Manufacturer Address
    W & H DentalWerk Buermoos GMBH, 53 Ignaz-Glazer-Strasse, Burmoos Austria
  • Source
    USFDA