Events

Recall of Device Recall Radius Rod Persuader

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

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
    46938
  • Event Risk Class
    Class 2
  • Event Number
    Z-1377-2008
  • Event Initiated Date
    2008-02-19
  • Event Date Posted
    2008-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68576
  • 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
    The t-bar of the radius rod persuader devices froze due to a loosening screw causing the device to fail.
  • Action
    Recall notification was sent via FedEx on February 19, 2008 to all branches/agencies. All questions are to be directed to Michelle Klein, Regulatory Compliance Specialist - 201-760-8256.

Device

Device Recall Radius Rod Persuader
  • Model / Serial
    Lot Codes 067805, 067806, 067807, 06D694. Catalog number: 486619190
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.
  • Product Description
    Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA