Events

Recall of Device Recall Stryker Spine Oasys Midline Occiput Plate

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
    65777
  • Event Risk Class
    Class 1
  • Event Number
    Z-1976-2013
  • Event Initiated Date
    2013-05-30
  • Event Date Posted
    2013-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120122
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • Reason
    Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
  • Action
    Stryker Spine sent a 'Urgent Medical Device Removal Letter'/'Customer Response Form' to Branch Managers, Agent Principals, Quality Contacts, Hospital OR Risk Managers, OR supervisor on 5/30/2013 via Fed Ex. Inventory should be examined and returned.The attached form should be completed and returned as well. Stryker Spine sent 'Urgent Medical Device Removal Letters' to Spinal Implant Surgeons on 6/20/2013 via Fed Ex.

Device

Device Recall Stryker Spine Oasys Midline Occiput Plate
  • Model / Serial
    K093670   Catalog numbers:  Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048  All lots of the above
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long || 5) Mini. || Allows for positioning directly on the midline keel of the occiput.
  • Manufacturer
    Stryker Spine

Manufacturer

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