Events

Recall of Device Recall Zimmer HGP II Acetabular Components Bone Screw

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
    35784
  • Event Risk Class
    Class 2
  • Event Number
    Z-1346-06
  • Event Initiated Date
    2006-06-26
  • Event Date Posted
    2006-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46953
  • 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
    bone screw - Product Code HWC
  • Reason
    Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
  • Action
    Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.

Device

Device Recall Zimmer HGP II Acetabular Components Bone Screw
  • Model / Serial
    Lots 12662700, 12718800, 12718900, 12757600, 12808600, 13331900, 13776600, 13776700, 13935600, 14196100, 14238900, 15590000, 15590100, 15610700, 16419200, 16579200, 16718400, 16718500, 16718600, 43764000, 48387800, 49078400, 49539800, 51295600, 52044900, 57690600, 57690800, 58905500, 59114400, 59476000, 66527800, 66527900, 66816800, 68890400, 68890500, 68890600 and 69606300.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
  • Product Description
    Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535).
  • Manufacturer
    Zimmer Inc.

Manufacturer

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