Events

Recall of Device Recall Achillon minimally invasive Achilles tendon suture system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology 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
    29559
  • Event Risk Class
    Class 2
  • Event Number
    Z-1304-04
  • Event Initiated Date
    2004-07-02
  • Event Date Posted
    2004-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34102
  • 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
    Suture Removal Kit - Product Code MCZ
  • Reason
    Lack of sterility assurance.
  • Action
    Wright Medical Technology notified its consignees via email and telephone to ensure that the email was received. The consignees asked to return any in-stock recalled product to Wright Medical Technology.

Device

Device Recall Achillon minimally invasive Achilles tendon suture system
  • Model / Serial
    Product: Achillon Reference No.: 119 700  Batch No.: C Sterilization Batch No.: S037
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Achillon¿ minimally invasive Achilles tendon suture system
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Road, P.O. Box 100, Arlington TN 38002-0100
  • Source
    USFDA