Events

Recall of Medline Total Knee CDS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    63520
  • Event Risk Class
    Class 2
  • Event Number
    Z-0532-2013
  • Event Initiated Date
    2012-09-20
  • Event Date Posted
    2012-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114135
  • 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
    General surgery tray (kit) - Product Code LRO
  • Reason
    The back table cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.
  • Action
    Medline Industries Inc notified the sole direct account on September 20, 2012 via telephone that the affected custom pack were recalled. Instruction was provided to the staff at the facility not to use the pack until it had been reworked with a sterile back table cover.

Device

Medline Total Knee CDS
  • Model / Serial
    Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) in the state of West Virginia
  • Product Description
    Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; || Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA