Events

Recall of MaxLock Extreme ModFoot Concave Reamer

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
    69294
  • Event Risk Class
    Class 2
  • Event Number
    Z-0062-2015
  • Event Initiated Date
    2014-09-19
  • Event Date Posted
    2014-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130183
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Incorrect sizing was being laser etched on the maxlock extreme mod-foot concave reamer.
  • Action
    An Urgent - Medical Device Recall customer notification, dated September 19, 2014, was sent out via email and FEDEx to all distributors with instructions on returning the product. The letter identified the affected product and the reason for the recall. Customers are to immediately cease distribution of the affected product, and complete and return the questionnaire. The letter also states that the recalled product will be replaced. Questions are to be directed to the Customer Service Department 1-888-494-7950.

Device

MaxLock Extreme ModFoot Concave Reamer
  • Model / Serial
    Part Number: MFT-074-CC-24; Lot: 3164011
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
  • Product Description
    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. || Used during procedures to clear away bone and cartilage within the desired implant area.
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1065 Medina Rd Ste 500, Medina OH 44256-5376
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA