Events

Recall of Detachable THandle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, Lp.

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
    33988
  • Event Risk Class
    Class 2
  • Event Number
    Z-0328-06
  • Event Initiated Date
    2005-10-21
  • Event Date Posted
    2005-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42855
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    Detachable t-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
  • Action
    The firm initiated the recall on 10/21/05 via letter to all consignees.

Device

Detachable THandle
  • Model / Serial
    Revision G (instrument not tracked by lot number).
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Device distributed nationwide to direct accounts in AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, MO, MT, NM, NH, NJ, OK, OH, PA, SC, SD, TX, UT, VA, and WA. Foreign distribution to Saudi Arabia, Japan and Germany.
  • Product Description
    Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA