Events

Recall of Stryker LUXOR RETRACTOR

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
    62648
  • Event Risk Class
    Class 2
  • Event Number
    Z-2155-2012
  • Event Initiated Date
    2012-04-23
  • Event Date Posted
    2012-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111265
  • 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
    Retractor - Product Code GAD
  • Reason
    Stryker received three reports involving blades of the luxor retractor becoming disassembled from the base causing the retractor to collapse insitu.
  • Action
    Stryker sent Urgent Product Recall letters/return response forms dated April 23, 2012 via FedEx to Stryker branches/agencies and hospitals where product might have been distributed. The letter identified the affected product, discussed the issue, potential hazards, risk mitigations, and the return process. Customers are to examine their inventory and reconcile any of the affected product with the information provided. In addition, the Customer Response Form should be completed and faxed back to Regulatory Compliance at 201-760-8370 within 5 days of receipt of the letter. The affected product should also be returned following the instructions provided. Questions should be directed to Dan Roberts, Regulatory Affairs Compliance Specialist at 201-760-8298.

Device

Stryker LUXOR RETRACTOR
  • Model / Serial
    Lot Code: 093309
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.
  • Product Description
    LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. || Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.
  • Manufacturer
    Stryker Spine

Manufacturer

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