Events

Recall of Device Recall Stryker AVS Navigator

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
    61723
  • Event Risk Class
    Class 2
  • Event Number
    Z-2033-2012
  • Event Initiated Date
    2012-01-13
  • Event Date Posted
    2012-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108786
  • 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
    Beginning in february 2011, stryker spine began receiving reports related to the shaft of the avs navigator trial failing at the junction of the trial head.
  • Action
    Stryker sent an "URGENT PRODUCT RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was included for customers to complete and return via fax to Regulatory Compliance at 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this recall.

Device

Device Recall Stryker AVS Navigator
  • Model / Serial
    Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Stryker AVS Navigator Trials 6mm-15mm || Manufactured by: || Stryker Spine SAS || Z.1 Marticot-33610-Cestas -France || +33 (0) 5.57.97.06.30 || http;//www.stryker.com || Distributed in the USA by || Stryker Spine || 2 Pearl Court. Allendale || NJ 07401-1677 USA || +1-201-780-8000 || Cestas France 33610. || Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
  • Manufacturer
    Stryker Spine

Manufacturer

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