Events

Recall of Device Recall MaxLock Screwdriver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthohelix Surgical Designs 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
    34498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0598-06
  • Event Initiated Date
    2005-11-01
  • Event Date Posted
    2006-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43950
  • 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
    Plate, Fixation, Bone - Product Code HRS
  • Reason
    Screwdriver pilot taper tip can break during surgery.
  • Action
    Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.

Device

Device Recall MaxLock Screwdriver
  • Model / Serial
    lot #11298
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.
  • Product Description
    MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1815 W Market Street, Suite 205, Akron OH 44313
  • Source
    USFDA