Events

Recall of Device Recall IBD Disc Space Distractor

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
    57462
  • Event Risk Class
    Class 2
  • Event Number
    Z-0895-2011
  • Event Initiated Date
    2010-12-07
  • Event Date Posted
    2011-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96281
  • 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 spine has received reports of the disc space distractors failing during surgical procedures.
  • Action
    Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced. Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. Return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance, Stryker Spine 6 Pearl Court Allendale, New Jersey 07401 For questions regarding this recall call 201-760-8206.

Device

Device Recall IBD Disc Space Distractor
  • Model / Serial
    Catalog number # IS2346AVS; All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, FL, MA, NY, PA, and TX
  • Product Description
    Disc Space Distractor || Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 || Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.
  • Manufacturer
    Stryker Spine

Manufacturer

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