Events

Recall of Device Recall AltiVate Reverse, HUMERAL SOCKET SHELL TRIAL, STANDARD

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
    79353
  • Event Risk Class
    Class 2
  • Event Number
    Z-1241-2018
  • Event Initiated Date
    2018-01-30
  • Event Date Posted
    2018-03-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162109
  • 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
    shoulder prosthesis, reverse configuration - Product Code PHX
  • Reason
    Broken or missing screws and retaining clips. this may be due to screw tolerance and material strength of the trial.
  • Action
    The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.

Device

Device Recall AltiVate Reverse, HUMERAL SOCKET SHELL TRIAL, STANDARD
  • Model / Serial
    Lot Codes: 183312L03, 200006L01, 224643L01
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. || Product Usage: || The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
  • 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