Events

Recall of Xcelerate Patella Reamer Shaft Assembly and Adapter

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
    47829
  • Event Risk Class
    Class 2
  • Event Number
    Z-1778-2008
  • Event Initiated Date
    2005-04-15
  • Event Date Posted
    2008-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70289
  • 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
    The xcelerate patella reamer shaft assembly and the reamer adapter do not mate properly. this could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.
  • Action
    An IMPORTANT MARKET WITHDRAWAL letter was issued on April 19, 2005 and sent Federal Express to those consignees who received the device. The letter instructed them to examine their inventory to identify instruments, reconcile these instruments on an attached accountability form; fax a copy of this form within 2 days of receipt of the letter; retrieve and return affected product; contact Stryker Customer Service to re-order.

Device

Xcelerate Patella Reamer Shaft Assembly and Adapter
  • Model / Serial
    Product no. 8001-1702; Lot codes: MCYL30A, and MCYL30B.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.
  • Product Description
    Xcelerate Patella System Reamer Shaft Assembly; || Non-Sterile; || Howmedica Osteonics Corp., || 325 Corporate Drive; || Mahwah, NJ 07430 || Authorized representative in Europe: || Stryker France ZAC Satolas Green Pusignan || Cedex, France
  • 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