Events

Recall of Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter

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
    53858
  • Event Risk Class
    Class 2
  • Event Number
    Z-0529-2010
  • Event Initiated Date
    2009-11-11
  • Event Date Posted
    2009-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86691
  • 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
    Patella Cutter - Product Code HTS
  • Reason
    Disposable patella cutters - 30 mm (catalog number 8000-0030, lot v31257001) were packaged and labeled as 33 mm disposable patella cutters (catalog number 8000-0033, lot v31257001 and vice versa.
  • Action
    An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.

Device

Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter
  • Model / Serial
    Catalog Number 8000-0033; Lot code V31257001.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (MA, NJ, FL, TN, OR and NY).
  • Product Description
    Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; || Stainless Steel, Disposable; || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || 33 mm size, One single unit to a package. || Note: The 30 mm instruments were not distributed. || The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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