Events

Recall of Device Recall 510003707 Most Option Stem Distractor

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
    60342
  • Event Risk Class
    Class 2
  • Event Number
    Z-0861-2012
  • Event Initiated Date
    2011-11-15
  • Event Date Posted
    2012-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105072
  • 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
    Fractured tips: any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site.
  • Action
    Urgent Device Correction Letters, dated October 28, 2011, which included revised Surgical Technique to be used in the Zimmer Most Option Wedge Stem Distractor were sent November 15, 2011 to all Distributors requiring Correction letters be sent to all Hospital Risk Managers and Surgeons receiving devices. Directions were provided to destroy all previous versions of the surgical technique, and review the attached revised surgical technique, with warnings of proper direction of force needed for safe separation of mated components. A FAX -Back Certificate of Acknowledgement is to be sent to (574) 372-4265. Call Zimmer at 1-877-946-2761 with questions or concerns.

Device

Device Recall 510003707 Most Option Stem Distractor
  • Model / Serial
    Lots 1519123, 1616672, 1627174, 60281712, 60773654, 60795066, 60841064, 61061148, 61348637, and 61770544.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US, including states of TX, IN, GA, WI, MN, NJ, MO, IL, VA, MI, PA, NC, OR, FL, KS, NY, AZ, CO, and UT and country of Switzerland.
  • Product Description
    5100-03-707 -- MOST Option STEM DISTRACTOR || MATL: SS NONSTERILE QTY-1 || Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components, implant connections and fixation of the implants.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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