Events

Recall of Device Recall Columbus 4IN1 Femoral Cutting Guide M3 Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap, 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
    63223
  • Event Risk Class
    Class 2
  • Event Number
    Z-0082-2013
  • Event Initiated Date
    2012-05-09
  • Event Date Posted
    2012-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113061
  • 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
    The manufacturer informed the recalling firm of a potential laser marking error in size identification on two columbus 4-in-1 femoral cutting guide instruments. the guides are correctly dimensioned, but the laser markings have been incorrectly etched.
  • Action
    Both consignees were notified verbally on May 15, 2012 and asked to inspect their inventory for the recalled items, remove the mislabeled instruments and return them to the recalling firm. Both mislabeled instruments were returned to the firm. Customer questions were directed to (610) 984-9074.

Device

Device Recall Columbus 4IN1 Femoral Cutting Guide M3 Instrument
  • Model / Serial
    NQ083R
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Within the US, product was distributed to PA and TN.
  • Product Description
    Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
  • Manufacturer
    Aesculap, Inc.

Manufacturer

Aesculap, Inc.
  • Manufacturer Address
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA