Events

Recall of Scorpio Adjustable Femoral A/P Sizing Guide

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
    56931
  • Event Risk Class
    Class 2
  • Event Number
    Z-0927-2011
  • Event Date Posted
    2011-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95002
  • 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
    Stryker orthopaedics has become aware that there is a potential for the shoulder screw on the scorpio sizing guide (the "sizing guide") to disassociate from the main body of the instrument.
  • Action
    Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.

Device

Scorpio Adjustable Femoral A/P Sizing Guide
  • Model / Serial
    Catalog Number 8000-0313  Lot numbers: RD2M081 RD2MO80 RD2N006 RD2N006E RD2L054 RD2M080E RD2S005X1 RD2S005 RD2S060 RD2N006S RD2S060S RD2S059 RD2V064 RD2V063 RD2V067 RD2V068 RD2V067A RD2V064E RD2V068S RD3A027 RD3A027M RD2V067M RD3A011 RD3A010 RD3A010A RD2VO68M RD3A011H RD3A009 RD2V068H RD3A027H RDA070H RD3A069 RD3A069H RD3A070 RD3L033 RD3N205 RD3N205X1 RD3S020 RD3S094 RD3V086
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.
  • Product Description
    Scorpio Adjustable Femoral A/P Sizing Guide Assembly; || non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation || The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.
  • 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