Events

Recall of Zimmer Trabecular Metal Modular Acetabular System

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
    59503
  • Event Risk Class
    Class 2
  • Event Number
    Z-3279-2011
  • Event Initiated Date
    2011-09-01
  • Event Date Posted
    2011-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102997
  • 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
    Prothesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Reason
    Lot # 61132698 and lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. the groove provides the locking ring room to displace when inserting a liner into the shell. th.
  • Action
    Zimmer, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 27, 2011 to all affected customers of lot 61132698 and 9/18/2012 to only affected customer of lot 001122467. The letters describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop using and to quarantine the affected product. An Inventory Return Certification Form was included with the letter for customers to complete and return to Zimmer, Inc. via fax at (574) 372-4265. Replacement product will be provided for all returned product. Contact Zimmer, Inc. at 1-800-613-6131 for questions regarding this recall.

Device

Zimmer Trabecular Metal Modular Acetabular System
  • Model / Serial
    Part 00-6202-052-21, Lot 61132698 and lot 001122467
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.
  • Product Description
    The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. || The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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