Events

Recall of Device Recall ReUnion

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    38775
  • Event Risk Class
    Class 2
  • Event Number
    Z-0080-2008
  • Event Initiated Date
    2007-05-09
  • Event Date Posted
    2007-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54383
  • 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 - Product Code KWS
  • Reason
    The plasma spray may delaminate from the proximal portion of the humeral stem.
  • Action
    Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards.

Device

Device Recall ReUnion
  • Model / Serial
    Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612. All lot codes.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    One hospital in Akron OH and 12 Stryker branches/agencies
  • Product Description
    ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. || Distal Diameter - 7 to 15mm; || Hydroxylapatite coated; || Titanium Plasma Spray; || Howmedica Osteonics Corp.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA