Events

Recall of Device Recall Repose G2 Bone Screw System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Xomed, 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
    52837
  • Event Risk Class
    Class 2
  • Event Number
    Z-0535-2010
  • Event Initiated Date
    2009-07-27
  • Event Date Posted
    2009-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84111
  • 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
    Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea - Product Code LRK
  • Reason
    Medtronic xomed, inc. is recalling the repose bone screw system product and bone screw product due to improper labeling. the labeling for the repose system was inadvertently placed on the repose screw and vice versa.
  • Action
    Firm notified customers by phone on 7/27/2009. Firm asked customers to check inventories for the affected products listed on the enclosed Checklist. 1. Fill-in the "quantity on-hand "column on the checklist. 2. If you have any this product lot, contact Medtronic ENT Customer Service at 800-874-5797 (select Option 1 for Customer Service) and ask for the REPOSE Field Action Contact Person for help to arrange for returns and replacements or credit. 3. Fax your Checklist to Medtronic ENT at the number provided. 4. Return products clearly marked.

Device

Device Recall Repose G2 Bone Screw System
  • Model / Serial
    Lot # 62450300
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    9 consignees in the continental United States.
  • Product Description
    Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. || Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. || The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Manufacturer Address
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA