Events

Recall of Device Recall Zimmer Allen medullary cement plugs

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
    52227
  • Event Risk Class
    Class 2
  • Event Number
    Z-1699-2009
  • Event Initiated Date
    2009-06-08
  • Event Date Posted
    2009-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82570
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Reason
    The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
  • Action
    Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.

Device

Device Recall Zimmer Allen medullary cement plugs
  • Model / Serial
    Lot Number: 61239672.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Canada and Japan.
  • Product Description
    Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile, Zimmer, Warsaw, Indiana; Catatog Number: 00801102001. || Total joint arthroplasty to control, restrict, or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Intramedullary canal must be plugged.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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