Events

Recall of Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    57341
  • Event Risk Class
    Class 2
  • Event Number
    Z-0824-2011
  • Event Initiated Date
    2010-10-29
  • Event Date Posted
    2010-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95899
  • 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
    Intramedullary Fixation Rod and Accessories - Product Code HSB
  • Reason
    The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. the manufacturing process created a step in the lumen which impedes the lag screw retaining shaft from passing through the lumen without the use of excessive force.
  • Action
    The firm sent Correction and Removal Notification Immediate Response Required letters via email to consignees. The letter identified the affected product and the reason for the recall. The letters also discussed the clinical implications and required actions. Customers are to complete the inventory certification form and user facility documentation form. Each of the affected accounts will be provided with a new instrument, manufactured with the correct lumen diameter and will secure and return the affected instruments per the attached notification, along with the completed inventory certification form. If any further information is needed, customers are to contact Aimee Wood at 574-372-4463.

Device

Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long
  • Model / Serial
    Lot Numbers: 00111903 and 07890923.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of MI, NJ, MS, OR, KS, TN, A, UT, and CA and countries of Belgium and Germany, Spain, Italy, Greece, France, UK, and Switzerland.
  • Product Description
    Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50, Zimmer, Warsaw, IN. || A reusable surgical instrument used for the insertion of a Lag Screw used in the Zimmer Natural Nail system.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA