Events

Recall of Device Recall XIA 3 Polyaxial Screw

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
    54271
  • Event Risk Class
    Class 2
  • Event Number
    Z-0823-2010
  • Event Initiated Date
    2009-12-30
  • Event Date Posted
    2010-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88077
  • 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
    Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease - Product Code NKB
  • Reason
    The xia 3 8.5mm polyaxial screws, lot a91109 were anodized turquoise instead of fuchsia. the turquoise color is reserved for the 9.5 mm xia 3 screws.
  • Action
    Stryker Spine branches that received the recalled product were notified of the recall by an Urgent Product Recall letter, dated January 15, 2010, sent via Federal Express. The letter identified the affected product and the issue involved. It also discussed the potential hazards, risk mitigation, and the return process. Customers are to examine their inventory and hospital locations to identify the product. Customers are also to reconcile the product by utilizing the Customer Response Form and distribution sheet. In addition, they are to retrieve and return the affected product. Questions should be directed to Tiffani Rogers at 201-760-8206.

Device

Device Recall XIA 3 Polyaxial Screw
  • Model / Serial
    Lot number: A91109
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- IL, MO, DA, MA and CO.
  • Product Description
    Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. || Not Sterile; || Manufactured by Stryker Spine, SA, Cestas, France. || Distributed in the USA by Stryker Spine, Allendale, NJ || Intended for use in the noncervical spine.
  • Manufacturer
    Stryker Spine

Manufacturer

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