Events

Recall of Device Recall Glenoid Head Inserter (RSP Inserter/Impactor)

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
    56220
  • Event Risk Class
    Class 2
  • Event Number
    Z-2636-2010
  • Event Initiated Date
    2010-07-12
  • Event Date Posted
    2010-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92992
  • 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
    Complaints indicate product's distal threaded tip may fracture under certain circumstances.
  • Action
    DJO Surgical sent an "Urgent Field Safety Notice" Letter dated July 12, 2010, to all of their consignees. The letter described the product, the problem, and the action consignees should take. Consignees were instructed to: Contact their Customer Service Representative for an R-RPR (RMS) number and return all RSP Glenoid Head Inserters, 804-03-041, under the assigned number to receive credit. Complete and return the Field Safety Notice Response to the firm. Identify and inform any customers who were sold or received the product of the Field Safety Notice Any questions consignees should call the firm at (512) 834-6330.

Device

Device Recall Glenoid Head Inserter (RSP Inserter/Impactor)
  • Model / Serial
    Device Part #804-03-041, All Lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of AR, AZ, CA, FL, GA, ID, IL, IN, LA, MA, ME, MI, MO, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, and WI; and the countries of Puerto Rico, Germany, and Saudi Arabia.
  • Product Description
    Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. || Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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