Events

Recall of Turon Glenoid Reamer

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
    77930
  • Event Risk Class
    Class 2
  • Event Number
    Z-3102-2017
  • Event Initiated Date
    2017-08-04
  • 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=158249
  • 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
    Reamer - Product Code HTO
  • Reason
    It was reported that the models used to manufacture s-200956/958 had the wrong dimension used to create the spherical radius cutting surface. device design allows a larger spherical radius cutting surface than intended.
  • Action
    The firm initiated their recall by telephone and email to their sales representatives and surgeons on 08/04/2017. The letter explained the problem and advised the surgeons that the sales representative would be collecting the devices for return.

Device

Turon Glenoid Reamer
  • Model / Serial
    Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    OH, VA
  • Product Description
    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: || REF S-200956 - 5mm PIN, SIZE 46 || REF S-200957 - 5mm PIN, SIZE 50 || REF S-200958 - 5mm PIN, SIZE 58
  • 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