Events

Recall of Device Recall Linear Hip Neck Trials

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
    74484
  • Event Risk Class
    Class 2
  • Event Number
    Z-2242-2016
  • Event Initiated Date
    2016-06-21
  • Event Date Posted
    2016-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147751
  • 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, porous uncemented - Product Code LPH
  • Reason
    Reported failure of the instrument. the retaining ring component of a neck trial became disassembled from the body of the neck.
  • Action
    The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices.

Device

Device Recall Linear Hip Neck Trials
  • Model / Serial
    Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CO, ID, TX
  • Product Description
    MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Manufacturer Parent Company (2017)
    The Blackstone Group LP
  • Source
    USFDA