Events

Recall of Device Recall Reflex Revision Screwdriver Inner Shaft

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
    48699
  • Event Risk Class
    Class 2
  • Event Number
    Z-2238-2008
  • Event Initiated Date
    2008-06-05
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71927
  • 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, screwdriver - Product Code HXX
  • Reason
    The inner shaft does not extend far enough from the tip of the revision screwdriver to fully engage the bone screw.
  • Action
    URGENT PRODUCT RECALL letters were sent to all branches/agencies who received the product on June 5, 2008. If you have questions, contact Michelle Klein at 201-760-8256.

Device

Device Recall Reflex Revision Screwdriver Inner Shaft
  • Model / Serial
    Lot codes: 26719, 047377, 047570, 065167, 06A167, and 072689.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to 13 Stryker branches/agencies.
  • Product Description
    Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Ref Number 48500900;Non Sterile
  • Manufacturer
    Stryker Spine

Manufacturer

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