Events

Recall of Impaction fixture

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
    72229
  • Event Risk Class
    Class 2
  • Event Number
    Z-0180-2016
  • Event Initiated Date
    2015-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140477
  • 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
    Impactor - Product Code HWA
  • Reason
    During the assembly, the impaction forces caused the polymer, black acetal copolymer from the impaction fixture to wear off on the lateral surface of the humeral stem titanium plasma spray coating.
  • Action
    DJO Global sent an Urgent Field Safety Notice dated September 15, 2015, to all affected consignees. The notice identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed become familiar with the new techniques and notify all of their applicable users of the RSP Monoblock and Turon stems of these revised methods. When each user has been notified of these new techniques, they should complete the form that was provided with the notification indicating that they have been informed of these changes and understand the new methods. Consignees were asked to complete and return forms. Consignees with questions should call 512-834-6255.

Device

Impaction fixture
  • Model / Serial
    Lot # 52748L02A
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 || The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.
  • 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